HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
FDA premarket approval P850010/S070 · decided 2016-10-07
Approval details
- PMA number
- P850010
- Supplement
- S070
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2016-02-26
- Decision date
- 2016-10-07
- Days to decision
- 224 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, NJ
- Statement
- Approval for the installation, operation and environmental monitoring validations for the addition of three HEPA Flow Stations in the Integra Packaging Room 304 at Integra LifeSciences, 105 Morgan Lane, Plainsboro, New Jersey.
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