INDERMIL TISSUE ADHESIVE
FDA premarket approval P010002/S003 · decided 2003-01-31
Approval details
- PMA number
- P010002
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INDERMIL TISSUE ADHESIVE
- Generic name
- Tissue adhesive for the topical approximation of skin
- Applicant
- Covidien Lp, Formerly Registered AS United States
- Date received
- 2002-12-13
- Decision date
- 2003-01-31
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MPN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Norwalk, CT
- Statement
- APPROVAL FOR THE ADDITION OF A PATIENT INSTRUCTION SHEET TO THE APPROVED LABELING.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS (K091869) | Covidien Lp, Formerly Registered AS United States | 2009-09-01 |
| ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE (K091900) | Covidien Lp, Formerly Registered AS United States | 2009-07-16 |
| AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS (K083519) | Covidien Lp, Formerly Registered AS United States | 2009-04-10 |
| SILS STITCH ENDOSCOPIC SUTURING DEVICE (K090419) | Covidien Lp, Formerly Registered AS United States | 2009-03-09 |
| SILS PORT, MODELS SILSPT5, SILSPT12 (K082619) | Covidien Lp, Formerly Registered AS United States | 2008-11-07 |
| MODIFIED ENDO STICH (K082659) | Covidien Lp, Formerly Registered AS United States | 2008-09-19 |
| AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR (K081169) | Covidien Lp, Formerly Registered AS United States | 2008-05-23 |