HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT
FDA premarket approval P850010/S014 · decided 1993-06-08
Approval details
- PMA number
- P850010
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 1992-07-06
- Decision date
- 1993-06-08
- Days to decision
- 337 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
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