PMA P870072S051

Device
THORATEC VENTRICULAR ASSIST DEVICE (VAD)
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S051
Product code
DSQ
Decision date
2012-11-29
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
ADDITION OF AUTOMATED EQUIPMENT FOR THE ANNEALING PROCESS OF THE DEVICE.

Current openFDA PMA Record#

Device
THORATEC VENTRICULAR ASSIST DEVICE (VAD)
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S051
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2012-11-29
Decision code
OK30
Date received
2012-10-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AUTOMATED EQUIPMENT FOR THE ANNEALING PROCESS OF THE DEVICE.