PMA P870072S034

Device
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S034
Product code
DSQ
Decision date
2007-06-28
Generic name
Ventricular (assist) bypass
Approval order statement
APPROVAL FOR A MATERIAL CHANGE IN THE TUBING THAT CONNECTS THE BODY OF THE PARACORPOREAL THORATEC VENTRICULAR ASSIST DEVICE WITH THE METAL Y-CONNECTOR THAT SPLITS THE LINE INTO SEPARATE ELECTRICAL AND PNEUMATIC CONNECTIONS.

Current openFDA PMA Record#

Device
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S034
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2007-06-28
Decision code
APPR
Date received
2006-07-12
Supplement type
Real-Time Process
Approval order statement
APPROVAL FOR A MATERIAL CHANGE IN THE TUBING THAT CONNECTS THE BODY OF THE PARACORPOREAL THORATEC VENTRICULAR ASSIST DEVICE WITH THE METAL Y-CONNECTOR THAT SPLITS THE LINE INTO SEPARATE ELECTRICAL AND PNEUMATIC CONNECTIONS.