PMA P810006S047

Device: COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE & MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S047
Product code: LMF
Decision date: 2014-04-04
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENT FROM METRIZYME (FORMULATED ENZYMATIC CLEANER) TO CIP-100 (FORMULATED ALKALINE CLEANER); 2) ESTABLISHMENT OF AN EQUIPMENT DIRTY HOLD TIME (DHT) OF 24-HOURS; 3) UTILIZATION OF 70% ISOPROPYL ALCOHOL (IPA), AS REQUIRED; 4) UTILIZATION OF SODIUM LAURYL SULFATE (SLS), AS REQUIRED; AND5) ESTABLISHING THE USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.

Current openFDA PMA Record#

Device: COLLASTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE & MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S047
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2014-04-04
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) CHANGE IN CLEANING DETERGENT FROM METRIZYME (FORMULATED ENZYMATIC CLEANER) TO CIP-100 (FORMULATED ALKALINE CLEANER); 2) ESTABLISHMENT OF AN EQUIPMENT DIRTY HOLD TIME (DHT) OF 24-HOURS; 3) UTILIZATION OF 70% ISOPROPYL ALCOHOL (IPA), AS REQUIRED; 4) UTILIZATION OF SODIUM LAURYL SULFATE (SLS), AS REQUIRED; AND5) ESTABLISHING THE USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES.