Avitene Microfibrillar Collagen Hemostat (MCH)
FDA premarket approval P800002/S023 · decided 2018-08-01
Approval details
- PMA number
- P800002
- Supplement
- S023
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Avitene Microfibrillar Collagen Hemostat (MCH)
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- C.R. Bard, Inc.
- Date received
- 2018-06-28
- Decision date
- 2018-08-01
- Days to decision
- 34 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Alternate in-process test method and test equipment (digital meter) used for % Ethanol determination during AviteneTM Microfibrillar Collagen Hemostat bulk flour production.
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