COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING
FDA premarket approval P840062/S022 · decided 2012-03-19
Approval details
- PMA number
- P840062
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2011-08-18
- Decision date
- 2012-03-19
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR THE ADDITION OF AN ADDITIONAL TRADE MAME, FROM ORACOTE, TO THE COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY PRODUCTS.
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