PMA P800002S016
- Device
- AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY PRODUCTS
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S016
- Product code
- LMF
- Decision date
- 2009-04-17
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- CHANGES IN THE STERILIZATION VALIDATION METHOD.
Current openFDA PMA Record#
- Device
- AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) FAMILY PRODUCTS
- Applicant
- C.R. Bard, Inc.
- PMA number
- P800002
- Supplement
- S016
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2009-04-17
- Decision code
- OK30
- Date received
- 2009-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES IN THE STERILIZATION VALIDATION METHOD.