AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB
FDA premarket approval P800002/S032 · decided 2025-02-18
Approval details
- PMA number
- P800002
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 2024-11-12
- Decision date
- 2025-02-18
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- approval for changes made to the Avitene product familys labeling, including the instructions for use (IFU), during the European Union (EU) Medical Device Regulation (MDR) transition.
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