PMA P060040S012

Device
THORATEC HEARTMATE II LVAS
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S012
Product code
DSQ
Decision date
2010-10-27
Classification
Ventricular (assist) Bypass
Generic name
Ventricular (assist) bypass
Approval order statement
APPROVAL FOR A MODIFICATION TO THE HEARTMATE II PATIENT POWER CABLE CONNECTORS.

Current openFDA PMA Record#

Device
THORATEC HEARTMATE II LVAS
Applicant
ABBOTT MEDICAL
PMA number
P060040
Supplement
S012
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2010-10-27
Decision code
APPR
Date received
2010-08-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A MODIFICATION TO THE HEARTMATE II PATIENT POWER CABLE CONNECTORS.