PMA P050044S032
- Device
- VITAGEL RT3 SURGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S032
- Product code
- LMF
- Decision date
- 2015-07-16
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- MODIFICATIONS TO THE ON-GOING REAL TIME STABILITY STUDY WHICH IS USED FOR ESTABLISHING SHELF LIFE FOR VITAGEL RT3 SURGICAL HEMOSTAT.
Current openFDA PMA Record#
- Device
- VITAGEL RT3 SURGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S032
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2015-07-16
- Decision code
- OK30
- Date received
- 2015-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATIONS TO THE ON-GOING REAL TIME STABILITY STUDY WHICH IS USED FOR ESTABLISHING SHELF LIFE FOR VITAGEL RT3 SURGICAL HEMOSTAT.