COLLASTAT
FDA premarket approval P810006/S071 · decided 2016-10-07
Approval details
- PMA number
- P810006
- Supplement
- S071
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLASTAT
- 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
- Planisboro, NJ
- Statement
- Approval for 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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