COSTASIS/DYNASTAT SURGICAL HEMOSTAT
FDA premarket approval P990030/S002 · decided 2001-12-21
Approval details
- PMA number
- P990030
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COSTASIS/DYNASTAT SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Angiotech Medical Device Technologies
- Date received
- 2001-11-20
- Decision date
- 2001-12-21
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE COSTASIS(R)/DYNASTAT(TM) SURGICAL HEMOSTATS' PRODUCT LABELING.
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