Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and EndoAvitene
FDA premarket approval P800002/S025 · decided 2019-06-21
Approval details
- PMA number
- P800002
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and EndoAvitene
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 2019-05-20
- Decision date
- 2019-06-21
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Change to in-process manufacturing test methods and in process bioburden monitoring specifications of the Avitene bulk flour component prior to sterilization.
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