PMA P870072S053

Device
THORATEC VENTRICULAR ASSIST DEVICE (VAD)
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S053
Product code
DSQ
Decision date
2013-06-21
Generic name
Ventricular (assist) bypass
Approval order statement
APPROVAL FOR THE CHANGE IN SECONDARY PACKAGING OF THE VAD SEALED ARTERIAL CANNULA AND THE INTERMEDIATE BULK SHIPMENT CONFIGURATION.

Current openFDA PMA Record#

Device
THORATEC VENTRICULAR ASSIST DEVICE (VAD)
Applicant
Thoratec Laboratories Corp.
PMA number
P870072
Supplement
S053
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2013-06-21
Decision code
APPR
Date received
2013-04-22
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE CHANGE IN SECONDARY PACKAGING OF THE VAD SEALED ARTERIAL CANNULA AND THE INTERMEDIATE BULK SHIPMENT CONFIGURATION.