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 in the method of terminal sterilization from e-beam to gamma irradiation and requested an additional 3-ml delivery syringe device with the associated labeling change.
| Device | COSTASIS(R)/DYNASTAT SURGICAL HEMOSTAT |
| Classification Name | Agent, Absorbable Hemostatic, Collagen Based |
| Generic Name | Agent, Absorbable Hemostatic, Collagen Based |
| Applicant | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES |
| Date Received | 2000-10-18 |
| Decision Date | 2001-01-02 |
| PMA | P990030 |
| Supplement | S001 |
| Product Code | LMF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES 3600 S.w 47th Avenue gainesville, FL 32608 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990030 | Original Filing | |
| S005 | 2004-08-23 | Normal 180 Day Track No User Fee |
| S004 | 2002-04-30 | Normal 180 Day Track |
| S003 | 2001-12-27 | Normal 180 Day Track |
| S002 | 2001-11-20 | Special (immediate Track) |
| S001 | 2000-10-18 | Real-time Process |