Collastat/INSTAT Absorbable Collagen Hemostatic Agent
FDA premarket approval P810006/S102 · decided 2023-02-23
Approval details
- PMA number
- P810006
- Supplement
- S102
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Collastat/INSTAT Absorbable Collagen Hemostatic Agent
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2023-01-27
- Decision date
- 2023-02-23
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Replacement of the current stainless-steel AT basket/paddle with a modular polyethylene/stainless steel AT basket to improve ergonomics and reduce wear particles as a result of paddle motion at the Integra LifeSciences Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, NJ 08536.
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