DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)
FDA premarket approval P960052 · decided 1998-08-26
Approval details
- PMA number
- P960052
- Trade name
- DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)
- Generic name
- Tissue adhesive for the topical approximation of skin
- Applicant
- Closure Medical Corp.
- Date received
- 1996-12-24
- Decision date
- 1998-08-26
- Days to decision
- 610 days
- Decision code
- APRL
- Product code
- MPN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- Yes
- Location
- Raleigh, NC
- Statement
- This device is indicated for topical application to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DermaBond(TM) may be used in conjunction with, but not in place of, subcuticular sutures.
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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 |