This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | Datascope Corp. |
| Date Received | 1991-07-26 |
| Decision Date | 1991-10-04 |
| PMA | P850023 |
| Supplement | S011 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |