HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P850010/S052 · decided 2014-05-07
Approval details
- PMA number
- P850010
- Supplement
- S052
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2014-04-10
- Decision date
- 2014-05-07
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- QUALIFICATION OF A NEW AIRLOCK ROOM.
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