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 change to the manufacturing process.
| Device | ABSORBABLE DUSTING POWDER |
| Applicant | KELLER AND HECKMAN |
| Date Received | 1995-02-27 |
| Decision Date | 1998-02-20 |
| PMA | N80023 |
| Supplement | S001 |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | KELLER AND HECKMAN 1001 G Street, N.w. suite 500 West washington, DC 20001 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N80023 | Original Filing | |
| S001 | 1995-02-27 | Normal 180 Day Track |