THORATEC VENTRICULAR ASIST DEVICE
FDA premarket approval P870072/S012 · decided 2001-06-01
Approval details
- PMA number
- P870072
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THORATEC VENTRICULAR ASIST DEVICE
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Laboratories Corp.
- Date received
- 2000-09-25
- Decision date
- 2001-06-01
- Days to decision
- 249 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Berkeley, CA
- Statement
- APPROVAL FOR THE ADDITION OF THE TLC-II PORTABLE PNEUMATIC DRIVER TO THE THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED TO BE INTERCHANGEABLE WITH THE DUAL DRIVE CONSOLE IN THE (CURRENTLY APPROVED) THORATEC PARACORPOREAL VENTRICULAR DEVICE SYSTEM FOR EITHER BRIDGE TO TRANSPLANT PATIENTS OR FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED FOR USE
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 |