HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
FDA premarket approval P850010/S001 · decided 1986-01-17
Approval details
- PMA number
- P850010
- Supplement
- S001
- Trade name
- HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 1985-12-13
- Decision date
- 1986-01-17
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
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