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A longer introduction to Premarket Notification 510(k) is also available.

The file layout describes the data fields.

The FDA offers many helpful, additional resources such as the following:

The complete FDA Premarket Notification database is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use.

Updates and changes.

Time Period

Source Data File

Premarket Notification

Source

Stata

Stata 244

SAS

CSV

Desc

Most current month available

pmnlstmn.zip

txt

dta

dta

sas7bdat

csv

desc

1996-current

pmn96cur.zip

txt

dta

dta

sas7bdat

csv

desc

1991-1995

pmn9195.zip

txt

dta

dta

sas7bdat

csv

desc

1986-1990

pmn8690.zip

txt

dta

dta

sas7bdat

csv

desc

1981-1985

pmn8185.zip

txt

dta

dta

sas7bdat

csv

desc

1976-1980

pmn7680.zip

txt

dta

dta

sas7bdat

csv

desc

Pre-Stata13 had a string length limit of 244 characters.

Contact data@nber.org with questions, comments, or suggestions.

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