DERMABOND TOPICAL SKIN ADHESIVE (2-OCTYL CYANOACRYLATE)
FDA premarket approval P960052/S002 · decided 2001-04-04
Approval details
- PMA number
- P960052
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DERMABOND TOPICAL SKIN ADHESIVE (2-OCTYL CYANOACRYLATE)
- Generic name
- Tissue adhesive for the topical approximation of skin
- Applicant
- Closure Medical Corp.
- Date received
- 2001-03-12
- Decision date
- 2001-04-04
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MPN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- APPROVAL TO MODIFY THE LABELING IN ORDER TO CLARIFY THE INSTRUCTIONS FOR PREPARING AND STORING THE DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |