DERMABOND(R) TOPICAL SKIN ADHESIVE
FDA premarket approval P960052/S003 · decided 2001-11-19
Approval details
- PMA number
- P960052
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DERMABOND(R) TOPICAL SKIN ADHESIVE
- Generic name
- Tissue adhesive for the topical approximation of skin
- Applicant
- Closure Medical Corp.
- Date received
- 2001-04-10
- Decision date
- 2001-11-19
- Days to decision
- 223 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 STATEMENT IN THE LABELING THAT THE DEIVCE PROVIDES MICROBIAL BARRIER PROPERTIES.
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 |