PMA P050044S033
- Device
- VITAGEL RT3 SUTGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S033
- Product code
- PMX
- Decision date
- 2017-03-02
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Approval order statement
- New tray tooling fixture, new sealing parameters and increased outer tray dimensions.
Current openFDA PMA Record#
- Device
- VITAGEL RT3 SUTGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S033
- Product code
- PMX
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Decision date
- 2017-03-02
- Decision code
- OK30
- Date received
- 2017-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New tray tooling fixture, new sealing parameters and increased outer tray dimensions.