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 a sterilization site located at steris isomedix services, whippany, new jersey.
| Device | INSTAT COLLAGEN HEMOSTAT |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | ETHICON, INC. |
| Date Received | 2005-06-24 |
| Decision Date | 2005-07-22 |
| PMA | P830079 |
| Supplement | S016 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |