HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
FDA premarket approval P850010/S004 · decided 1987-03-31
Approval details
- PMA number
- P850010
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 1986-08-20
- Decision date
- 1987-03-31
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
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