PMA P880038

Device
META PACEMAKER
Applicant
St. Jude Medical, Inc.
PMA number
P880038
Supplement
S035
Product code
NVZ
Decision date
2006-07-11
Generic name
Pulse generator, permanent, implantable
Approval order statement
APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.

Current openFDA PMA Record

Device
META PACEMAKER
Applicant
St. Jude Medical, Inc.
PMA number
P880038
Supplement
S037
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2006-07-11
Decision code
APPR
Date received
2006-06-07
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE MODEL 3330 V4.0 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 V6.1.1M SOFTWARE FOR USE ON THE MODEL 3510 PROGRAMMER.

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