PMA P870072S056

Device
THORATEC VENTRICULAR ASSIST DEVICE (VAD)
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S056
Product code
DSQ
Decision date
2013-07-16
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
ADDITION OF A NEW DIRECTIONAL FLOW VALVE (DFV) LEAK TESTER.

Current openFDA PMA Record#

Device
THORATEC VENTRICULAR ASSIST DEVICE (VAD)
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S056
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2013-07-16
Decision code
OK30
Date received
2013-07-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW DIRECTIONAL FLOW VALVE (DFV) LEAK TESTER.