PMA P980012S001

Device
NOVACOR LVAS
Applicant
WORLD HEART, INC.
PMA number
P980012
Supplement
S001
Product code
DSQ 
Decision date
1999-12-21
Generic name
Ventricular (assist) Bypass
Approval order statement
Approval To Introduce The Novacor LVAS Compact Controllers With AutoTuning Software.

Current openFDA PMA Record

Device
NOVACOR LVAS
Applicant
Worldheart, Inc.
PMA number
P980012
Supplement
S001
Product code
DSQ
Generic name
Ventricular (assist) bypass
Decision date
1999-12-21
Decision code
APPR
Date received
1999-06-28
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to introduce the Novacor LVAS Compact Controllers with AutoTuning Software.

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