_dta: 1. by Jean Roth , jroth@nber.org , 15 Oct 2018 prodcode: 1. The device name variable contains descriptions associated with the product codes. sumstat: 1. SUMMARY indicates that a summary of safety and effectiveness information is available from FDA 2. STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant thirdparty: 1. When the device is a candidate for Third Party Review under the Accredited Persons program, 2. the following codes reflect whether it became eligible under the preexisting program or the expansions program. 3. Further information on this program can be found at: Third Party Review 4. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/default.htm devname: 1. The Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas. 2. Therefore, the first word in the device name is usually the best search parameter. 3. For example, to find a specific pump, search on the word "pump" to retrieve all products with the word "pump" in their name. obs: 23,316 vars: 27 15 Oct 2018 13:09 size: 9,279,768 (_dta has notes) ---------------------------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ---------------------------------------------------------------------------------------------------------------------------------------------------------------- knumber str7 %9s 510(K) Number applicant str50 %50s Applicant contact str33 %33s Contact street1 str34 %34s Street 1 street2 str30 %30s Street 2 city str30 %30s City state str2 %9s State country_code str2 %9s Country Code zip str10 %10s ZIP Code postal_code str10 %10s Foreign Postal Code recdatestr str10 %10s Date Received String recdate float %td Date Received decdatestr str10 %10s Decision Date String decdate float %td Decision Date decisionstr str4 %9s Decision String decision long %91.0g decision Decision String advcomstr str2 %9s Advisory Committee String advcom int %38.0g advcom Advisory Committee String prodcode str3 %9s * Product Code sumstatstr str9 %9s Either Summary or State String sumstat byte %103.0g sumstat * Either Summary or State String classadvcomstr str2 %9s Advisory Committee Code under which the product was classified, based on the pro classadvcom int %38.0g advcom Advisory Committee Code under which the product was classified, based on the pro type str11 %11s Type of 510(k) Submission thirdpartystr str1 %9s Third Party Flag String thirdparty byte %59.0g thirdparty * Third Party Flag String devname str120 %120s * Device Name * indicated variables have notes ---------------------------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: knumber prodcode decision: 6578 AN De Novo Petitions Granted 6782 CR Additional Information Requested; Applicant can not respond within 30 days 6783 CS Substantially Equivalent - CLIA Submission 6866 DB Forwarded to Drugs/Biologics 6868 DD Deleted/Duplicate 6869 DE Deleted 6882 DR Drug (CDER) Review Required 6988 EX Exempted by Regulation 7066 FB Subject to 515(b) - Requires PMA 7180 GP General Purpose Article 7276 Old? Typo? Substantively Equivalent? 7504 K4 Closeout Letter Issued 7568 KD Substantially Equivalent - Kit with Drugs 7865 NA Not Actively Regulated 7868 ND Not a Device 7869 NE Not Substantially Equivalent 7870 NF Not a Finished Product 7882 NR Not a Required Submission 7968 OD Unable to Determine Equivalence - Outstanding Device Issue 8069 PE Preamendment Exempt 8082 PR Substantially Equivalent - Proposed Recision 8084 PT Substantially Equivalent - Subject to Tracking & PMS 8267 RC Reconditioner/Remanufacturer 8269 RE Rescind Substantial Equivalence 8278 RN Substantially Equivalent - Rescind Non-Substantial Equivalence 8365 SA Substantially Equivalent - Awaiting Device Approval 8367 SC Not Substantially Equivalent - Cannot Market 8368 SD Substantially Equivalent with Drug 8369 SE Substantially Equivalent 8370 SF Substantially Equivalent - Awaiting Future Policies 8373 SI Substantially Equivalent - Market after Inspection 8375 SK Substantially Equivalent - Kit 8376 SL Not Substantially Equivalent - Improper Label 8378 SN Substantially Equivalent for Some Indications 8380 SP Substantially Equivalent - PostMarket Surveillance Required 8383 Old? Typo? Substantively Equivalent? 8384 ST Substantially Equivalent - Subject to Tracking Reg. 8385 SU Substantially Equivalent - With Limitations 8387 SW Substantially Equivalent - Awaiting Drug Approval 8482 TR Transitional Device 8568 UD Unable to Determine Equivalence 8579 UO Unable to Determine Equivalence - Outstanding Drug Issue 8582 UR Not Substantially Equivalent - Unreliable Data 8768 WD Withdrawn by Applicant 6.87e+07 DENG Decision granted 8.37e+07 SEKD Substantially Equivalent 8.37e+07 SESD Substantially Equivalent - Substantially Equivalent with Drug 8.37e+07 SESE Substantially Equivalent - Substantially Equivalent 8.37e+07 SESK Substantially Equivalent - Substantially Equivalent - Kit 8.37e+07 SESP Substantially Equivalent - Substantially Equivalent - PostMarket Surveillance Required 8.37e+07 SESU Substantially Equivalent - Substantially Equivalent - With Limitations advcom: 6578 Anesthesiology Part 868 AN 6772 Clinical Chemistry Part 862 CH 6786 Cardiovascular Part 870 CV 6869 Dental Part 872 DE 6978 Ear, Nose, & Throat Part 874 EN 7185 Gastroenterology & Urology Part 876 GU 7269 Hematology Part 864 HE 7279 General Hospital Part 880 HO 7377 Immunology Part 866 IM 7771 Molecular Genetics MG 7773 Microbiology Part 866 MI 7869 Neurology Part 882 NE 7966 Obstetrics/Gynecology Part 884 OB 7980 Ophthalmic Part 886 OP 7982 Orthopedic Part 888 OR 8065 Pathology Part 864 PA 8077 Physical Medicine Part 890 PM 8265 Radiology Part 892 RA 8369 Substantially Equivalent SE 8385 General & Plastic Surgery Part 878 SU 8488 Clinical Toxicology Part 862 TX 8.37e+07 Summary SESE sumstat: 0 SUMMARY indicates that a summary of safety and effectiveness information is available from FDA 1 STATEMENT indicates that safety and effectiveness information may be obtained from the 510(k) applicant advcom: 6578 Anesthesiology Part 868 AN 6772 Clinical Chemistry Part 862 CH 6786 Cardiovascular Part 870 CV 6869 Dental Part 872 DE 6978 Ear, Nose, & Throat Part 874 EN 7185 Gastroenterology & Urology Part 876 GU 7269 Hematology Part 864 HE 7279 General Hospital Part 880 HO 7377 Immunology Part 866 IM 7771 Molecular Genetics MG 7773 Microbiology Part 866 MI 7869 Neurology Part 882 NE 7966 Obstetrics/Gynecology Part 884 OB 7980 Ophthalmic Part 886 OP 7982 Orthopedic Part 888 OR 8065 Pathology Part 864 PA 8077 Physical Medicine Part 890 PM 8265 Radiology Part 892 RA 8369 Substantially Equivalent SE 8385 General & Plastic Surgery Part 878 SU 8488 Clinical Toxicology Part 862 TX 8.37e+07 Summary SESE thirdparty: 78 N = Not Eligible for Accredited Persons Program 80 P = Eligible for Accredited Persons Expansion Pilot Program 89 Y = Eligible for Accredited Persons Program