PMA P920014

Device: HEARTMATE XVE LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S031
Product code: DSQ
Decision date: 2011-12-21
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT THORATEC CORPORATION IN SAN RAMON, CALIFORNIA FOR RECEIVING ACCEPTANCE ACTIVITIES, RECEIVING INSPECTION, WAREHOUSING, AND SHIPPING OPERATIONS.

Current openFDA PMA Record#

Device: HEARTMATE XVE LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S031
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2011-12-21
Decision code: APPR
Date received: 2010-12-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT THORATEC CORPORATION IN SAN RAMON, CALIFORNIA FOR RECEIVING ACCEPTANCE ACTIVITIES, RECEIVING INSPECTION, WAREHOUSING, AND SHIPPING OPERATIONS.