PMA P050044S005
- Device
- VITAGEL SURGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S005
- Product code
- LMF
- Decision date
- 2008-05-30
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL TO CHANGE THE VENDOR OF THE 1 LITER AND 5 LITER MEDIA BAGS USED TO STORE INTERMEDIAE SOLUTIONS DURING VITAGEL ASEPTIC PROCESSING.
Current openFDA PMA Record#
- Device
- VITAGEL SURGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S005
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2008-05-30
- Decision code
- APPR
- Date received
- 2008-05-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO CHANGE THE VENDOR OF THE 1 LITER AND 5 LITER MEDIA BAGS USED TO STORE INTERMEDIAE SOLUTIONS DURING VITAGEL ASEPTIC PROCESSING.