PMA P920014S012

Device
HEARTMATE IP & VE LVAS
Applicant
Thoratec Corp
PMA number
P920014
Supplement
S012
Product code
DSQ
Decision date
2000-06-23
Generic name
Ventricular (assist) bypass
Approval order statement
APPROVAL FOR OUTFLOW GRAFT BEND RELIEF (OGER) AND FOR A MODIFICATION TO THE STAND ALONE OUTFLOW GRAFT.

Current openFDA PMA Record

Device
HEARTMATE IP & VE LVAS
Applicant
Thoratec Corp
PMA number
P920014
Supplement
S012
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2000-06-23
Decision code
APPR
Date received
2000-06-15
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR OUTFLOW GRAFT BEND RELIEF (OGER) AND FOR A MODIFICATION TO THE STAND ALONE OUTFLOW GRAFT.

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