PMA P920014S019

Device
HEARTMATE XVE LVAS
Applicant
Thoratec Corp
PMA number
P920014
Supplement
S019
Product code
DSQ
Decision date
2004-06-29
Generic name
Ventricular (assist) bypass
Approval order statement
APPROVAL OF THE POST APPROVAL STUDY FOR THE DEVICE.

Current openFDA PMA Record

Device
HEARTMATE XVE LVAS
Applicant
Thoratec Corp
PMA number
P920014
Supplement
S019
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
2004-06-29
Decision code
APPR
Date received
2003-02-07
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
APPROVAL OF THE POST APPROVAL STUDY FOR THE DEVICE.

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