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Device | COLLACOTE COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY |
Generic Name | MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID |
Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P840062 |
Supplement Number | S034 |
Date Received | 08/14/2013 |
Decision Date | 04/04/2014 |
Product Code |
LPG |
Advisory Committee |
Dental |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |