PMA P050044S031
- Device
- VITAGEL SURGICAL HEMOSTAT (RT3)
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S031
- Product code
- LMF
- Decision date
- 2015-04-14
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATIVE CLEANING PROCEDURE FOR EQUIPMENT AND COMPONENTS USED IN THE PRODUCTION OF VITAGEL RT3 SURGICAL HEMOSTAT.
Current openFDA PMA Record#
- Device
- VITAGEL SURGICAL HEMOSTAT (RT3)
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S031
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2015-04-14
- Decision code
- OK30
- Date received
- 2015-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN ALTERNATIVE CLEANING PROCEDURE FOR EQUIPMENT AND COMPONENTS USED IN THE PRODUCTION OF VITAGEL RT3 SURGICAL HEMOSTAT.