- Device
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S026
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2007-01-09
- Decision code
- OK30
- Date received
- 2006-12-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN MANUFACTURING PROCESS FOR A QC RELEASE TEST FOR FINISHED DEVICES USED IN THE COLLAGEN PURIFICATION PROCESS.