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 the addition of the manufacturing facility located in north yorkshire, united kingdom.
| Device | INSTAT COLLAGEN ABSORBABLE HEMOSTAT |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | ETHICON, INC. |
| Date Received | 2007-06-01 |
| Decision Date | 2007-11-28 |
| PMA | P830079 |
| Supplement | S017 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |