- Device
- Avitene Microfibrillar Collagen Hemostat (MCH)
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S023
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2018-08-01
- Decision code
- OK30
- Date received
- 2018-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate in-process test method and test equipment (digital meter) used for % Ethanol determination during AviteneTM Microfibrillar Collagen Hemostat bulk flour production.