AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT
FDA premarket approval P800002/S024 · decided 2018-12-26
Approval details
- PMA number
- P800002
- Supplement
- S024
- Supplement type
- 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
- 2018-12-03
- Decision date
- 2018-12-26
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Implement an autotitrator system to measure the in-process determination of acid content per gram of collagen and the in-process specification for residual hydrochloric acid content after acidification.
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