_dta: 1. by Jean Roth , jroth@nber.org , 12 Oct 2018 2. NBER URL: http://www.nber.org/data/fda-premarket-approval-application-database.html 3. Source Page: http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/pmaapprovals/default.htm 4. Source File URL: http://www.accessdata.fda.gov/premarket/ftparea/pma.zip 5. Source Text File: pma.txt 6. tradename has been truncated to 244 characters for pre-Stata13 7. aostatement has been truncated to 244 characters for pre-Stata13 prodcode: 1. See http://www.nber.org/data/fda-product-code-classification-database.html supplementtype: 1. Type of Supplement 2. THIRTY DAY TRACK 3. PANEL TRACK 4. SPECIAL(IMMEDIATE TRACK) 5. REAL-TIME PROCESS 6. 30-DAY NOTIFICATION 7. 135 REVIEW TRACK FOR 30-DAY NOTIFICATION supplementreason: 1. Primary Reason for Supplement 2. CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COLOR ADDITIVE 3. CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT 4. CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - MATERIAL 5. CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER 6. CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SOFTWARE 7. CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - SPECIFICATIONS 8. CHANGE IN LOCATION PILOT 9. DESIGN CHANGE - MINOR 10. LABELING CHANGE - INDICATIONS 11. LABELING CHANGE - INSTRUCTIONS 12. LABELING CHANGE - MINOR 13. LABELING CHANGE - OTHER 14. LABELING CHANGE - PERFORMANCE CHARACTERISTICS 15. LABELING CHANGE - SHELF-LIFE 16. LABELING CHANGE - TRADE NAME 17. LOCATION CHANGE - OTHER 18. LOCATION CHANGE: DISTRIBUTOR 19. LOCATION CHANGE: MANUFACTURER 20. LOCATION CHANGE: PACKAGER 21. LOCATION CHANGE: STERILIZER 22. POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL 23. PROCESS CHANGE - OTHER 24. PROCESS CHANGE: MANUFACTURING 25. PROCESS CHANGE: PACKAGING 26. PROCESS CHANGE: STERILIZATION 27. OTHER obs: 38,803 vars: 26 12 Oct 2018 13:35 size: 36,436,017 (_dta has notes) ------------------------------------------------------------------------------------------------------------------------------------------- storage display value variable name type format label variable label ------------------------------------------------------------------------------------------------------------------------------------------- pmanumber str7 %9s Premarket Approval Application (PMA) Number supnum str4 %9s Supplement Number applicant str50 %50s Applicant street_1 str43 %43s Street 1 street_2 str28 %28s Street 2 city str33 %33s City state str2 %9s State zip str5 %9s ZIP Code zip_ext str4 %9s ZIP Code Extension genericname str116 %116s Generic Name tradename str244 %244s Trade Name prodcode str3 %9s * Product Code advcomstr str2 %9s Advisory Committee String advcom int %38.0g advcom Advisory Committee String supplementtype str34 %34s * Supplement Type supplementreason str63 %63s * Supplement Reason review str1 %9s Review Granted (Y/N) recdatestr str10 %10s Date Received String recdate float %td Date Received decdatestr str10 %10s Decision Date String decdate float %td Decision Date docknum str8 %9s Docket Number frdatestr str10 %10s Date of Federal Register Notice (mm-dd-yyyy) String frdate float %td Date of Federal Register Notice (mm-dd-yyyy) deccode str4 %9s Decision Code aostatement str244 %244s Approval Order Statement * indicated variables have notes ------------------------------------------------------------------------------------------------------------------------------------------- Sorted by: pmanumber supnum 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 8385 General & Plastic Surgery Part 878 SU 8488 Clinical Toxicology Part 862 TX