PMA P800002S022
- Device
- Avitene® Microfibrillar Collagen Hemostat
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S022
- Product code
- LMF
- Decision date
- 2017-07-05
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Approval for the replacement of the automated blade cutting process with a die cutting machine.
Current openFDA PMA Record#
- Device
- Avitene® Microfibrillar Collagen Hemostat
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S022
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2017-07-05
- Decision code
- APPR
- Date received
- 2017-03-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the replacement of the automated blade cutting process with a die cutting machine.