PMA P900022

Device
Chorus Pacemakers
Applicant
MicroPort CRM USA Inc.
PMA number
P900022
Supplement
S005
Decision date
1998-11-18

Current openFDA PMA Record

Device
REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1
Applicant
MicroPort CRM USA, Inc.
PMA number
P900022
Supplement
S012
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2009-02-04
Decision code
APPR
Date received
2008-11-12
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE REPLY PACER EMBEDDED SOFTWARE W1.5.1 AND ASSOCIATED PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.10 UG1.

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