HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P850010/S029 · decided 2009-03-26
Approval details
- PMA number
- P850010
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2009-02-02
- Decision date
- 2009-03-26
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- APPROVAL FOR AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES.
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