PMA P800002
- Device
- Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web Webber
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S028
- Product code
- LMF
- Decision date
- 2026-09-29
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- modification of manufacturing equipment for Avitene™ MCH Non-Woven Web production
Current openFDA PMA Record#
- Device
- Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web Webber
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S036
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2026-09-29
- Decision code
- OK30
- Date received
- 2026-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modification of manufacturing equipment for Avitene™ MCH Non-Woven Web production