THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
FDA premarket approval P870072/S027 · decided 2004-08-03
Approval details
- PMA number
- P870072
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD)
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Laboratories Corp.
- Date received
- 2004-01-06
- Decision date
- 2004-08-03
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Berkeley, CA
- Statement
- APPROVAL FOR THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) AS AN ALTERNATE VAD BLOOD PUMP FOR USE IN THE APPROVED THORATEC VENTRICULAR ASSIST DEVICE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE AND 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
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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 |