THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
FDA premarket approval P870072 · decided 1995-12-20
Approval details
- PMA number
- P870072
- Trade name
- THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Laboratories Corp.
- Date received
- 1987-11-24
- Decision date
- 1995-12-20
- Days to decision
- 2948 days
- Decision code
- APWD
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Berkeley, CA
- Statement
- INTENDED AS A BRIDGE TO CARDIAC TRANSPLANTATION FOR USE IN PATIENTS SUFFERING FROM END-STAGE HEART FAILURE. THE PATIENT SHOULD MEET ALL OF THE FOLLOWING CRITERIA: 1)CANDIDATE FOR CARDIAC TRANSPLANTATION, 2) IMMINENT RISK OF DYING BEFORE DONOR HEART PROCUREMENT, AND 3) DEPENDENCE O N, OR INCOMPLETE RESPONSE TO, CONTINUE VASOPRESSOR SUPPORT
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 |
|---|---|---|
| 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 |