Avitene Microfibrillar Collagen Hemostat
FDA premarket approval P800002/S030 · decided 2023-10-04
Approval details
- PMA number
- P800002
- Supplement
- S030
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Avitene Microfibrillar Collagen Hemostat
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 2022-06-06
- Decision date
- 2023-10-04
- Days to decision
- 485 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Approval for a change of the total chloride test methodology used to determine the weight percent (wt. %) chloride in Avitene bulk flour.
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