THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
FDA premarket approval P870072/S026 · decided 2003-11-26
Approval details
- PMA number
- P870072
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE (PVAD) SYSTEM AND TLC-II PORTABLE VAD DRIVER
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Laboratories Corp.
- Date received
- 2003-07-03
- Decision date
- 2003-11-26
- Days to decision
- 146 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Berkeley, CA
- Statement
- APPROVAL TO EXPAND THE INDICATIONS FOR USE TO INCLUDE TRANSPORT OF PATIENTS IN FIXED WING AIRCRAFT AND IN HELICOPTERS. THIS DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM AND TLC-II PORTABLE VAD DRIVER. THE PVAD IS INDICATED FOR USE IN BRIDGE TO TRANSPLANT PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA: CANDIDATE FOR CARDIAC TRANSPLANTATION, IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, DEPENDENCE ON, OR INCOMPLETE RES
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME (K001927) | Thoratec Laboratories Corp. | 2000-12-18 |
| VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES (K001926) | Thoratec Laboratories Corp. | 2000-09-22 |
| THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY (K851495) | Thoratec Laboratories Corp. | 1985-08-01 |
| RESPIRATORY ASSESSMENT SYSTEM (K833714) | Thoratec Laboratories Corp. | 1983-12-29 |
| RESPIRATORY FLOW MODULE (K833265) | Thoratec Laboratories Corp. | 1983-11-28 |
| INTRAOPERATIVE AUTOTRANSFUSION SYS (K831557) | Thoratec Laboratories Corp. | 1983-08-24 |
| RESPIRATORY GAS ANALYZER (K823449) | Thoratec Laboratories Corp. | 1983-01-05 |
| RESPIRATORY CIRCUIT ADAPTOR (K823287) | Thoratec Laboratories Corp. | 1982-12-09 |