PMA P810006S046

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S046
Product code: LMF
Decision date: 2014-04-08
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CLEANING VALIDATION FOR THE MICROFIBRILLAR GRINDING PROCESS EQUIPMENT; 2) ESTABLISHMENT OF DIRTY HOLD TIME;3) TOTAL ORGANIC CARBON (TOC) RECOVERY STUDY FOR SWAB AND RINSE ON STAINLESS STEEL SURFACES; AND4) TOC RECOVERY STUDY FOR SWAB AND RINSE ON TEFLON SURFACES.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S046
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2014-04-08
Decision code: APPR
Date received: 2013-08-14
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CLEANING VALIDATION FOR THE MICROFIBRILLAR GRINDING PROCESS EQUIPMENT; 2) ESTABLISHMENT OF DIRTY HOLD TIME;3) TOTAL ORGANIC CARBON (TOC) RECOVERY STUDY FOR SWAB AND RINSE ON STAINLESS STEEL SURFACES; AND4) TOC RECOVERY STUDY FOR SWAB AND RINSE ON TEFLON SURFACES.