COLLACOTE COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
FDA premarket approval P840062/S034 · decided 2014-04-04
Approval details
- PMA number
- P840062
- Supplement
- S034
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLACOTE COLLATAPE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2013-08-14
- Decision date
- 2014-04-04
- Days to decision
- 233 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- 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.
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