PMA P060040S041

Device
THORATEC HEARTMATE II LVAS
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S041
Product code
DSQ
Decision date
2015-06-03
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
APPROVAL FOR THE UNSHIELDED 14V POWER MODULE PATIENT CABLE.

Current openFDA PMA Record#

Device
THORATEC HEARTMATE II LVAS
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S041
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2015-06-03
Decision code
APPR
Date received
2015-03-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE UNSHIELDED 14V POWER MODULE PATIENT CABLE.