PMA N17600S033
- Device
- Avitene Microfibrillar Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S033
- Product code
- LMF
- Decision date
- 2020-04-09
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- Change in the test method for the in-process measurement of hydroxyproline in Avitene bulk flour and finished product.
Current openFDA PMA Record#
- Device
- Avitene Microfibrillar Collagen Hemostat
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
- PMA number
- N17600
- Supplement
- S033
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2020-04-09
- Decision code
- OK30
- Date received
- 2020-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the test method for the in-process measurement of hydroxyproline in Avitene bulk flour and finished product.