- Device
- COLLASTAT/INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S061
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2015-04-01
- Decision code
- OK30
- Date received
- 2015-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- QUALIFICATION OF THE YOKOGAWA PAPERLESS CHART RECORDING SYSTEM AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.