VITAGEL SURGICAL HEMOSTAT
FDA premarket approval P990030 · decided 2000-06-13
Approval details
- PMA number
- P990030
- Trade name
- VITAGEL SURGICAL HEMOSTAT
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Applicant
- Angiotech Medical Device Technologies
- Date received
- 1999-06-07
- Decision date
- 2000-06-13
- Days to decision
- 372 days
- Decision code
- APWD
- Product code
- PMX
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- 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.
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