HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT
FDA premarket approval P850010/S015 · decided 1995-09-12
Approval details
- PMA number
- P850010
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT (R) ABSORBABLE COLLAGEN HEMOSTATIC AGENT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 1995-07-26
- Decision date
- 1995-09-12
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY FOR HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT AT GRIFFITH MICROSCIENCE, INC. 27 PARK ROAD, GLEN FALLS, NY 12801
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