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.