HIGH VISCOSITY DERMABOND MINI APPLICATOR
FDA premarket approval P960052/S011 · decided 2006-02-10
Approval details
- PMA number
- P960052
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIGH VISCOSITY DERMABOND MINI APPLICATOR
- Generic name
- Tissue adhesive for the topical approximation of skin
- Applicant
- Closure Medical Corp.
- Date received
- 2005-12-16
- Decision date
- 2006-02-10
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MPN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- APPROVAL FOR THE DESIGN CHANGE OF THE HIGH VISCOSITY DERMABOND APPLICATOR SO THAT IT HAS A REDUCED FILL VOLUME COMPARED TO THE ORIGINAL HIGH VISCOSITY DERMABOND APPLICATOR (0.325 GRAMS RATHER THAN -.565 GRAMS OF THE ORIGINAL PRODUCT). THE DEVICE, HIGH VISCOSITY DERMABOND MINI APPLICATOR, AS MODIFIED, IS INDICATED FOR ?TOPICAL APPLICATION TO HOLD CLOSED APPROXIMATED WOUND EDGES OF TRAUMA INDUCED LACERATIONS OR SURGICAL INCISIONS, INCLUDING PUNCTURES FROM MINIMALLY INVASIVE SURGERY, THAT OTHERWISE
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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 |