DERMABOND TOPICAL SKIN ADHESIVE
FDA premarket approval P960052/S007 · decided 2003-12-01
Approval details
- PMA number
- P960052
- Supplement
- S007
- Supplement type
- Special (Immediate Track)
- 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
- 2003-10-09
- Decision date
- 2003-12-01
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MPN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- APPROVAL FOR A LABELING CHANGE TO MODIFY A WARNING STATEMENT (6TH BULLET) TO READ, "HIGH VISCOSITY DERMABOND ADHESIVE SHOULD NOT BE USED IN HIGH SKIN TENSION AREAS OR ACROSS AREAS OF INCREASED SKIN TENSION, SUCH AS KNUCKLES, ELBOWS, OR KNEES, UNLESS THE JOINT WILL BE IMMOBILIZED DURING THE SKIN HEALING PERIOD OR UNLESS SKIN TENSION HAS BEEN REMOVED BY APPLICATION OF ANOTHER WOUND CLOSURE DEVICE (E.G., SUTURES OR SKIN STAPLES) PRIOR TO THE APPLICATION OF HIGH VISCOSITY DERMABOND ADHESIVE."
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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 |