PMA P050044S027
- Device
- RT3 SURGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S027
- Product code
- LMF
- Decision date
- 2014-01-27
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL OF THE TRANSFER OF STERILITY TESTING OF VITAGEL RT3 FILLED SYRINGES INHOUSE.
Current openFDA PMA Record#
- Device
- RT3 SURGICAL HEMOSTAT
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S027
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2014-01-27
- Decision code
- APPR
- Date received
- 2013-11-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL OF THE TRANSFER OF STERILITY TESTING OF VITAGEL RT3 FILLED SYRINGES INHOUSE.