COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
FDA premarket approval P840062/S033 · decided 2014-04-07
Approval details
- PMA number
- P840062
- Supplement
- S033
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2013-08-05
- Decision date
- 2014-04-07
- Days to decision
- 245 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) A NEW ALKALINE DETERGENT FOR USE AS A CLEANING AGENT; 2) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES; 3) SWAB AND RINSE RECOVERY FACTORS AND A VISUAL LIMIT OF DETECTION FOR MEDICAL MANUFACTURING AREA SOIL ON STAINLESS STEEL AND ALUMINUM SURFACES; 4) PROPOSED CHANGE IN EQUIPMENT DIRTY HOLD TIMES (DHTS) FOR THE DOUBLE DENSITY HEMOSTATIC DISPERSION, CROSS-LINKING PROCESS EQUIPMENT AND THE MOLD FILLING EQUIPMENT; AND5)
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