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 manufacturing site located at ethicon, inc. , in cornelia, georgia.
| Device | ETHICON OMNEX SURGICAL SEALANT |
| Generic Name | Sealant, Polymerizing |
| Applicant | ETHICON, INC. |
| Date Received | 2013-01-08 |
| Decision Date | 2014-01-17 |
| PMA | P060029 |
| Supplement | S005 |
| Product Code | NBE |
| Advisory Committee | Cardiovascular |
| 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 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 |