PMA N17600S035
- Device
- Avitene Microfibrillar Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S035
- Product code
- LMF
- Decision date
- 2021-02-17
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Changes to the secondary pouch material and supplier facility for Avitene Microfibrillar Collagen Hemostat.
Current openFDA PMA Record#
- Device
- Avitene Microfibrillar Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S035
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2021-02-17
- Decision code
- OK30
- Date received
- 2021-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the secondary pouch material and supplier facility for Avitene Microfibrillar Collagen Hemostat.