ORATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
FDA premarket approval P840062/S021 · decided 2010-12-03
Approval details
- PMA number
- P840062
- Supplement
- S021
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORATAPE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2010-08-27
- Decision date
- 2010-12-03
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR THE ADDITIONAL TRADE NAME, ORATAPE, TO THE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY PRODUCT.
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