PMA P970024

Device
LYRA(TM) ICD SYSTEMS
Applicant
MicroPort CRM USA, Inc.
PMA number
P970024
Supplement
S003
Product code
LWS
Decision date
2001-02-06
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
APPROVAL FOR THE FIRMWARE MODIFICATIONS IN THE LYRA(TM) ICD SYSTEMS.

Current openFDA PMA Record

Device
LYRA(TM) ICD SYSTEMS
Applicant
MicroPort CRM USA, Inc.
PMA number
P970024
Supplement
S004
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2001-02-06
Decision code
APPR
Date received
2000-11-30
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE FIRMWARE MODIFICATIONS IN THE LYRA(TM) ICD SYSTEMS.

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