PMA P810006S073

Device: COLLASTAT / INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S073
Product code: LMF
Decision date: 2016-09-15
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: Replacement of a portion of the water deionization system located in the Collagen Manufacturing Center at 105 Morgan Lane, Plainsboro, New Jersey, 08536.

Current openFDA PMA Record#

Device: COLLASTAT / INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S073
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2016-09-15
Decision code: OK30
Date received: 2016-08-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of a portion of the water deionization system located in the Collagen Manufacturing Center at 105 Morgan Lane, Plainsboro, New Jersey, 08536.