PMA P810006S044

Device: COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT, MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S044
Product code: LMF
Decision date: 2013-08-29
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.

Current openFDA PMA Record#

Device: COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE, COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT, MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S044
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2013-08-29
Decision code: OK30
Date received: 2013-07-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION.