Avitene Microfibrillar Collagen Hemostat
FDA premarket approval P800002/S026 · decided 2020-04-09
Approval details
- PMA number
- P800002
- Supplement
- S026
- 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
- 2020-02-28
- Decision date
- 2020-04-09
- Days to decision
- 41 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Change in the test method for the in-process measurement of hydroxyproline in Avitene bulk flour and finished product.
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