COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING
FDA premarket approval P840062/S019 · decided 2009-06-09
Approval details
- PMA number
- P840062
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING
- Generic name
- MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
- Applicant
- Integra Lifesciences Corp.
- Date received
- 2009-03-09
- Decision date
- 2009-06-09
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LPG
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Planisboro, NJ
- Statement
- APPROVAL FOR AN ADDITIONAL TRADE NAME, ORAPLUG, TO THE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING.
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