PMA P880006S068

Device
Sensolog/dialog/regency Family Of Pacemakers
Applicant
St. Jude Medical, Inc.
PMA number
P880006
Supplement
S068
Decision date
2010-10-01

Current openFDA PMA Record

Device
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Applicant
St. Jude Medical, Inc.
PMA number
P880006
Supplement
S068
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2010-10-01
Decision code
APPR
Date received
2010-07-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE MERLIN PCS SOFTWARE MODEL 3330 VERSION 10.1.1.2.

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