- Device
- COLLASTAT , ABSORABLE COLLAGEN HEMOSTATIC SPONGE, INSTANT MCH MICROFIBRILLAR COLLAGEN HEMOSTAT
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S050
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2014-01-17
- Decision code
- OK30
- Date received
- 2013-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO INTRODUCE AN ALTERNATE TEST METHOD FOR BACTERIAL ENDOTOXIN IN COLLAGEN PRODUCTS.