This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for costasis(r) surgical hemostat and dynastat(tm) surgical hemostat. This device is indicated for use in surgical procedures (other than in neurosurgical, ophthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
| Device | VITAGEL SURGICAL HEMOSTAT |
| Classification Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Generic Name | Absorbable Collagen Hemostatic Agent With Thrombin |
| Applicant | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES |
| Date Received | 1999-06-07 |
| Decision Date | 2000-06-13 |
| Notice Date | 2000-07-12 |
| PMA | P990030 |
| Supplement | S |
| Product Code | PMX |
| Docket Number | 00M-1368 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ANGIOTECH MEDICAL DEVICE TECHNOLOGIES 3600 S.w 47th Avenue gainesville, FL 32608 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |