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.
Approval for removal of the neurological exclusion from the "indications for use" statement. The device, as modified, will be marketed under the trade name instat absorbable collagen hemostat and is indicated for use "in surgical procedures (other than in ophthalmological surgery) as an adjunct to hemostasis when control of bleeding by ligature or other conventional procedures in ineffective or impractical. Instat hemostat can be cut to size for use in endoscopic procedures. "
| Device | INSTAT ABSORBABLE COLLAGEN HEMOSTAT |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | ETHICON, INC. |
| Date Received | 2003-08-25 |
| Decision Date | 2003-09-26 |
| PMA | P830079 |
| Supplement | S014 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ETHICON, INC. route 22 West p.o. Box 151 somerville, NJ 08876-0151 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830079 | Original Filing | |
| S017 | 2007-06-01 | Normal 180 Day Track |
| S016 | 2005-06-24 | Normal 180 Day Track No User Fee |
| S015 | 2004-04-28 | Normal 180 Day Track No User Fee |
| S014 | 2003-08-25 | Real-time Process |
| S013 | ||
| S012 | 1998-08-28 | Normal 180 Day Track |
| S011 | 1995-06-13 | Normal 180 Day Track |
| S010 | 1990-05-25 | Normal 180 Day Track |
| S009 | 1990-05-07 | Normal 180 Day Track |
| S008 | 1990-04-26 | Normal 180 Day Track |
| S007 | 1988-09-26 | Normal 180 Day Track |
| S006 | 1988-05-31 | Normal 180 Day Track |
| S005 | ||
| S004 | ||
| S003 | 1986-10-24 | Normal 180 Day Track |
| S002 | 1986-09-09 | Normal 180 Day Track |
| S001 | 1985-11-07 |