COLLACOTE, COLLAPLUG, COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
FDA premarket approval P840062/S008 · decided 2003-05-16
Approval details
- PMA number
- P840062
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COLLACOTE, COLLAPLUG, COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2003-04-16
- Decision date
- 2003-05-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- CHANGES AFFECTING MANUFACTURING PROCESSES INCLUDING: 1) QUALIFYING ADDITIONAL MANUFACTURING ROOM, 2) MODIFYING THE TEMPERATURE MONITORING METHOD, 3) ADDITION OF A DIFFERENT AGENT FOR CLEANSING THE MANUFACTURING AREA, AND 4) MODIFYING THE METHOD FOR DRYING THE WEIGHED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.
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