DERMABOND TOPICAL SKIN ADHESIVE
FDA premarket approval P960052/S006 · decided 2003-06-13
Approval details
- PMA number
- P960052
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DERMABOND TOPICAL SKIN ADHESIVE
- Generic name
- Tissue adhesive for the topical approximation of skin
- Applicant
- Closure Medical Corp.
- Date received
- 2003-05-01
- Decision date
- 2003-06-13
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- MPN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- APPROVAL FOR TWO CHANGES TO THE LABELING: 1) CHANGE THE INSTRUCTIONS FOR USE TO STATE THAT TWO LAYERS OF ADHESIVE SHOULD BE APPLIED INSTEAD OF THREE LAYERS AND 2) THE ADDITION OF LANGUAGE STATING THAT THE DEVICE CAN ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN INTACT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PRINEO SKIN CLOSURE SYSTEM (DEN090005) | Closure Medical Corp. | 2010-04-30 |
| LIQUIDERM LIQUID ADHESIVE BANDAGE (K002338) | Closure Medical Corp. | 2001-01-29 |
| SOOTHE-N-SEAL CANKER SORE RELIEF (K991923) | Closure Medical Corp. | 1999-09-02 |
| OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 (K980159) | Closure Medical Corp. | 1998-04-09 |