HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
FDA premarket approval P850010/S042 · decided 2013-08-29
Approval details
- PMA number
- P850010
- Supplement
- S042
- 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
- 2013-07-31
- Decision date
- 2013-08-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.
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