Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo
FDA premarket approval P810006/S103 · decided 2023-04-18
Approval details
- PMA number
- P810006
- Supplement
- S103
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2023-03-20
- Decision date
- 2023-04-18
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- Address a modification to the reporting language of relevant regulatory standard(s). Other than in the reporting units, the proposed change did not stem from or cause a change to any test methods or product release specifications. A 3-year retrospective analysis of the potential effect of the change did not raise any issues related to past product release decisions, and therefore no future product release issues are predicted by the proposed change.
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