PMA P810006S039

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S039
Product code: LMF
Decision date: 2013-06-18
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: CHANGES IN CLEANING DETERGENT, DIRTY EQUIPMENT HOLD TIMES, AND CLEANING METHODS.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC AGENT
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S039
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-06-18
Decision code: OK30
Date received: 2013-05-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES IN CLEANING DETERGENT, DIRTY EQUIPMENT HOLD TIMES, AND CLEANING METHODS.