HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE
FDA premarket approval P960052/S010 · decided 2005-03-21
Approval details
- PMA number
- P960052
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE
- Generic name
- Tissue adhesive for the topical approximation of skin
- Applicant
- Closure Medical Corp.
- Date received
- 2005-02-09
- Decision date
- 2005-03-21
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- MPN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- APPROVAL FOR THE ADDITION OF PROPEN AND PROPEN XL APPLICATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES HIGH VISCOSITY DERMABOND PROPEN TOPICAL ADHESIVE AND HIGH VISCOSITY DERMABOND PROPEN XL TOPICAL SKIN ADHESIVE PRODUCTS AND ARE INDICATED FOR TOPICAL APPLICATION 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 DE
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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 |