Avitene Bulk Flour Cleanroom Expansion
FDA premarket approval P800002/S031 · decided 2024-01-18
Approval details
- PMA number
- P800002
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Avitene Bulk Flour Cleanroom Expansion
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 2023-12-21
- Decision date
- 2024-01-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- proposed to expand the cleanroom of the manufacturing site
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.