DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY
FDA premarket approval P960052/S004 · decided 2002-12-31
Approval details
- PMA number
- P960052
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY
- Generic name
- Tissue adhesive for the topical approximation of skin
- Applicant
- Closure Medical Corp.
- Date received
- 2001-05-01
- Decision date
- 2002-12-31
- Days to decision
- 609 days
- Decision code
- APPR
- Product code
- MPN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- APPROVAL FOR THE ADDITION OF A HIGHER VISCOSITY PRODUCT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE AND IS INTENDED FOR TOPICAL APPLICATION ONLY TO HOLD CLOSED EASILY APPROXIMATED SKIN EDGES OF WOUNDS FROM SURGICAL INCISIONS, INCLUDING PUNCTURES FROM MINIMALLY INVASIVE SURGERY, AND SIMPLE, THOROUGHLY CLEANSED, TRAUMA-INDUCED LACERATIONS. HIGH VISCOSITY DERMABOND ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP
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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 |