PMA P870072S057

Device
THORATEC VENTRICULAR ASSIST DEVICE(VAD)
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S057
Product code
DSQ
Decision date
2013-12-18
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
APPROVAL FOR A CHANGE TO THE FINAL INSPECTION OF THE THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM.

Current openFDA PMA Record#

Device
THORATEC VENTRICULAR ASSIST DEVICE(VAD)
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S057
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2013-12-18
Decision code
APPR
Date received
2013-11-21
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A CHANGE TO THE FINAL INSPECTION OF THE THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM.