PMA P920014S029

Device
THORATEC HEARTMATE XVE LVAS
Applicant
Thoratec Corp
PMA number
P920014
Supplement
S029
Product code
DSQ
Decision date
2009-03-13
Generic name
Ventricular (assist) bypass
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE EXTERNAL PERIPHERALS.

Current openFDA PMA Record#

Device
THORATEC HEARTMATE XVE LVAS
Applicant
Thoratec Corp
PMA number
P920014
Supplement
S029
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2009-03-13
Decision code
APPR
Date received
2008-07-17
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE EXTERNAL PERIPHERALS.