PMA P870072S013

Device
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S013
Product code
DSQ
Decision date
2001-10-31
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
APPROVAL FOR DESIGN CHANGES OF THE TUNNELER USED TO FACILITATE IMPLANTATION OF THE THORATEC VAD CANNULAE.

Current openFDA PMA Record#

Device
THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S013
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2001-10-31
Decision code
APPR
Date received
2000-10-30
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR DESIGN CHANGES OF THE TUNNELER USED TO FACILITATE IMPLANTATION OF THE THORATEC VAD CANNULAE.