PMA P800002S033
- Device
- Avitene Microfibrillar Collagen Hemostat
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S033
- Product code
- LMF
- Decision date
- 2025-03-13
- Classification
- General, Plastic Surgery
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- for a new tray sealer for the Ultrafoam product line and to change the sampling plan for incoming foil pouches for all Avitene products
Current openFDA PMA Record#
- Device
- Avitene Microfibrillar Collagen Hemostat
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S033
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2025-03-13
- Decision code
- OK30
- Date received
- 2025-02-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for a new tray sealer for the Ultrafoam product line and to change the sampling plan for incoming foil pouches for all Avitene products