PMA P800002
- Device
- Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S028
- Product code
- LMF
- Decision date
- 2026-07-15
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- updated water system equipment for the Woburn, MA manufacturing site
Current openFDA PMA Record#
- Device
- Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S035
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2026-07-15
- Decision code
- OK30
- Date received
- 2026-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updated water system equipment for the Woburn, MA manufacturing site