COSTASIS SURGICAL HEMOSTAT
FDA premarket approval P990030/S004 · decided 2002-06-13
Approval details
- PMA number
- P990030
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COSTASIS SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Angiotech Medical Device Technologies
- Date received
- 2002-04-30
- Decision date
- 2002-06-13
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Gainesville, FL
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT COHESION TECHNOLOGIES, PALO ALTO, CALIFORNIA.
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