PMA P880086S113

Device
IMPLANTABLE PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S113
Product code
NVZ
Decision date
2006-03-02
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.

Current openFDA PMA Record#

Device
IMPLANTABLE PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S113
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2006-03-02
Decision code
APPR
Date received
2006-01-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODEL 3330 VERSION 1.2 SOFTWARE SUPPORTING THE MICRONY/REGENCY AND FRONTIER DEVICES ON THE MODEL 3650 MERLIN PROGRAMMER.