PMA P810006S048

Device: COLLASTAR INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S048
Product code: LMF
Decision date: 2014-03-18
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR ADDING INCREASED SYSTEM CAPACITY FOR WATER PURIFICATION OF THE CURRENT REVERSE OSMOSIS/ELECTRO-DEIONIZATION WATER PURIFICATION SYSTEM (ROEDI).

Current openFDA PMA Record#

Device: COLLASTAR INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S048
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2014-03-18
Decision code: APPR
Date received: 2013-11-01
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR ADDING INCREASED SYSTEM CAPACITY FOR WATER PURIFICATION OF THE CURRENT REVERSE OSMOSIS/ELECTRO-DEIONIZATION WATER PURIFICATION SYSTEM (ROEDI).