This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Device | HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT |
Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
Applicant | Datascope Corp. |
Date Received | 1985-04-17 |
Decision Date | 1986-05-27 |
Notice Date | 1986-07-07 |
PMA | P850023 |
Supplement | S |
Product Code | LMF |
Docket Number | 86M-0248 |
Advisory Committee | General & Plastic Surgery |
Expedited Review | No |
Combination Product | No |
Applicant Address | Datascope Corp. 14 Philips Pkwy. montvale, NJ 07645 |
Supplement Number | Date | Supplement Type |
---|---|---|
P850023 | Original Filing | |
S014 | 1994-06-27 | Normal 180 Day Track |
S013 | 1992-05-22 | Normal 180 Day Track |
S012 | ||
S011 | 1991-07-26 | Normal 180 Day Track |
S010 | 1991-07-12 | Normal 180 Day Track |
S009 | 1989-12-08 | Normal 180 Day Track |
S008 | 1988-09-06 | Normal 180 Day Track |
S007 | ||
S006 | 1987-10-22 | Normal 180 Day Track |
S005 | 1987-09-04 | Normal 180 Day Track |
S004 | 1987-06-17 | Normal 180 Day Track |
S003 | 1987-03-26 | Normal 180 Day Track |
S002 | 1986-10-29 | Normal 180 Day Track |
S001 | 1986-08-12 | 30-Day Supplement |