PMA P810006S030
- Device
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S030
- Product code
- LMF
- Decision date
- 2007-11-23
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- MODIFICATION AND RE-QUALIFICATION OF AN EXISTING CLEAN ROOM USED TO MANUFACTURE COLLAGEN HEMOSTATIC AGENTS.
Current openFDA PMA Record#
- Device
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S030
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2007-11-23
- Decision code
- OK30
- Date received
- 2007-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION AND RE-QUALIFICATION OF AN EXISTING CLEAN ROOM USED TO MANUFACTURE COLLAGEN HEMOSTATIC AGENTS.