PMA P920014S025

Device: HEARTMATE LVAS SYSTEM
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S025
Product code: DSQ
Decision date: 2005-03-22
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT TRI-STATE HOSPITAL SUPPLY CORPORATION, YUMA, ARIZONA AND FOR A CHANGE IN THE CYTOTOXICITY TESTING PROCESS.

Current openFDA PMA Record

Device: HEARTMATE LVAS SYSTEM
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S025
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2005-03-22
Decision code: APPR
Date received: 2004-12-27
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT TRI-STATE HOSPITAL SUPPLY CORPORATION, YUMA, ARIZONA AND FOR A CHANGE IN THE CYTOTOXICITY TESTING PROCESS.