- Device
- AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB & ENDOAVITENE
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S017
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2011-09-29
- Decision code
- OK30
- Date received
- 2011-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO QUALITY CONTROL TESTING FOR INCOMING RAW MATERIAL (BOVINE CORIUM) AND MODIFICATION TO FINISHED GOODS TESTING.