PMA P810006S049
- Device
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S049
- Product code
- LMF
- Decision date
- 2014-10-31
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- Approval order statement
- APPROVAL FOR A CHANGE IN CLEANING VALIDATION PROCESS FOR MANUFACTURING EQUIPMENT.
Current openFDA PMA Record#
- Device
- COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- Applicant
- Integra LifeSciences Corporation
- PMA number
- P810006
- Supplement
- S049
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2014-10-31
- Decision code
- APPR
- Date received
- 2013-11-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN CLEANING VALIDATION PROCESS FOR MANUFACTURING EQUIPMENT.