THORATEC TLC-II PORTABLE VAD DRIVER
FDA premarket approval P870072/S037 · decided 2007-11-14
Approval details
- PMA number
- P870072
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THORATEC TLC-II PORTABLE VAD DRIVER
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Laboratories Corp.
- Date received
- 2007-07-30
- Decision date
- 2007-11-14
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Berkeley, CA
- Statement
- APPROVAL FOR REDUCING THE MAINTENANCE SERVICE INTERVAL FOR THE TLC II PORTABLE VAD DRIVER TO 1500 HOURS FROM THE CURRENT 3000 HOUR INTERVAL.
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 |