PMA P060040S014

Device: HEARTMATE II LVAS
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S014
Product code: DSQ
Decision date: 2011-12-21
Classification: Ventricular (assist) Bypass
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 II LVAS
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S014
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.