HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT
FDA premarket approval P850010/S045 · decided 2014-04-04
Approval details
- PMA number
- P850010
- Supplement
- S045
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Integra LifeSciences Corporation
- Date received
- 2013-08-14
- Decision date
- 2014-04-04
- Days to decision
- 233 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plainsboro, 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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