Thoratec Corporation

FDA Filings

This page includes the latest FDA filings for Thoratec Corporation. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Thoratec Corporation (now Part Of Abbott)
CentriMag Acute Circulatory Support System2019-07-10
THORATEC LABORATORIES CORP.
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME2000-12-18

Latest Premarket Applications

PMAManufacturerDevice NameDate
THORATEC CORP.
HeartMate II Left Ventricular Assist System (LVAS)2019-09-12
Thoratec Corporation
HeartMate 3 Left Ventricular Assist System (LVAS)2019-09-12
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System2019-08-25
THORATEC CORP.
HeartMate II Left Ventricular Assist System (LVAS)2019-08-12
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System (LVAS)2019-08-12
Thoratec Corporation
HeartMate 3 (HM3) Left Ventricular Assist System (LVAS)2019-05-01
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)2019-01-18
Thoratec Corporation
HeartMate 3 Left Ventricular Assist System2019-01-08
Thoratec Corporation
Thoratec HeartMate 3™ Left Ventricular Assist System (LVAS)2018-11-09
Thoratec Corporation
HeartMate 3 Left Ventricular Assist System2018-10-18
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System (LVAS)2018-10-05
THORATEC CORP.
HeartMate II Left Ventricular Assist System (LVAS)2018-09-20
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)2018-09-12
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System (LVAS)2018-09-12
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System (LVAS)2018-08-24
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System pump rotor sub-assembly2018-08-06
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System (LVAS)2018-07-05
THORATEC CORP.
HeartMate ll Left Ventricular Assist System (LVAS)2018-06-01
Thoratec Corporation
HeartMate 3 Left Ventricular Assist System (LVAS)2018-06-01
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System2018-05-31
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System2018-05-18
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System2018-01-16
THORATEC CORP.
HeartMate II Left Ventricular Assist System2017-10-12
THORATEC CORP.
Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS)2017-10-12
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System2017-10-12
Thoratec Corporation
Thoratec HeartMate II and HeartMate 3 Ventricular Assist System (LVAS)2017-10-12
Thoratec Corporation
HeartMate 3™ Left Ventricular Assist System2017-08-23
THORATEC CORP.
Thoratec, HeartMate II, Ventricular Assist System2017-08-17
THORATEC CORP.
HEARTMATE II LVAS2017-06-30
THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM2017-06-23

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Thoratec® Stabilization Belt (L-XL)
Thoratec Corporation2019-10-07
THORATEC® STABILIZATION BELT (S-M)
Thoratec Corporation2019-10-07
CMAG TRANSPORTER, SPARE PART KIT
Thoratec Switzerland GmbH2019-10-04
SQUARE OXYGENATOR BRACKET
Thoratec Switzerland GmbH2019-10-04
CIRCULAR OXYGENATOR BRACKET LARGE
Thoratec Switzerland GmbH2019-10-04
CIRCULAR OXYGENATOR BRACKET MEDIUM
Thoratec Switzerland GmbH2019-10-04
CIRCULAR OXYGENATOR BRACKET SMALL
Thoratec Switzerland GmbH2019-10-04
CENTRIMAG™ System Transporter
Thoratec Switzerland GmbH2019-10-04
Thoratec® HeartMate 3™ Surgical Hand Tools
Thoratec Corporation2019-06-20
HeartMate®, 14V Li-ion Rechargeable Battery Set
Thoratec Corporation2019-06-20
HEARTMATE, 14V LI-ION RECHARGEABLE BATTERY SET (SING)
Thoratec Corporation2019-06-20
THORATEC® PVAD™, VENTRICULAR ASSIST DEVICE - BLOOD PUMP
Thoratec Corporation2019-06-20
HEARTMATE®, 14V LI-ION BATTERY CLIP SET
Thoratec Corporation2019-06-20
Thoratec® HeartMate 3™
Thoratec Corporation2019-05-31
Thoratec® HeartMate 3™
Thoratec Corporation2019-05-31
Thoratec® HeartMate 3™
Thoratec Corporation2019-05-31
Thorate® VAD, Surgical Implant Accessory Kit
Thoratec Corporation2019-05-16
THORATEC® ONE TUNNELER ASSEMBLY SHORT STANDARD CURVE
Thoratec Corporation2019-05-16
THORATEC® PVAD™, LVAD ELECTRICAL LEAD 5FT
Thoratec Corporation2019-05-09
Thoratec PVAD, Cannula Tunneler
Thoratec Corporation2019-05-08
HeartMate® 14VLi-Ion Rechargeable Replacement Battery (SING)
Thoratec Corporation2019-05-08
THORATEC® HEARTMATE II®, TUNNELER
Thoratec Corporation2019-05-08
HeartMate®, 14V Rechargeable Li-ion Battery
Thoratec Corporation2019-05-06
HeartMate II®, System Controller
Thoratec Corporation2019-05-06
Thoratec® HeartMate® ICU Cover (1 Pack)
Thoratec Corporation2019-04-01
HeartMate II®, System Controller
Thoratec Corporation2019-04-01
HEARTMATE MOBILE POWER UNIT, CA
Thoratec Corporation2019-04-01
HeartMate® 11V Li-Ion Backup Battery
Thoratec Corporation2019-04-01
THORATEC® HEARTMATE®, TRAVEL BAG
Thoratec Corporation2019-04-01
Thoratec® HeartMate 3™
Thoratec Corporation2019-03-27
Thoratec® HeartMate 3™
Thoratec Corporation2019-03-11
HEARTMATE® POWER MODULE (NA)
Thoratec Corporation2019-03-01
THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL
Thoratec Corporation2019-03-01
HEARTMATE®, DATA CARD
Thoratec Corporation2019-03-01
HeartMate® 14VLi-Ion Rechargeable Replacement Batt
Thoratec Corporation2019-02-28

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