PMA P810006S053

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS-MICROFIBRILLAR FORM, COLLASTAT ABSORABLE COLAGEN HEMOSTATIC SPONGE
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S053
Product code: LMF
Decision date: 2014-10-17
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR THE IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, FOR THE DEVICES.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS-MICROFIBRILLAR FORM, COLLASTAT ABSORABLE COLAGEN HEMOSTATIC SPONGE
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S053
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2014-10-17
Decision code: APPR
Date received: 2014-04-11
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, FOR THE DEVICES.