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.
Transfer of the incoming inspection process from ethicon, inc. In raleigh, north carolina to ethicon llc in san lorenzo, puerto rico.
| Device | ETHICON OMNEX SURGICAL SEALANT |
| Generic Name | Sealant, Polymerizing |
| Applicant | ETHICON, INC. |
| Date Received | 2012-05-29 |
| Decision Date | 2012-06-29 |
| PMA | P060029 |
| Supplement | S004 |
| Product Code | NBE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ETHICON, INC. route 22 West somerville, NJ 08876 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P060029 | Original Filing | |
| S005 | 2013-01-08 | Normal 180 Day Track |
| S004 | 2012-05-29 | 30-day Notice |
| S003 | 2011-06-29 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 | 2010-07-09 | Real-time Process |