PMA P880086S122

Device
VARIOUS MODELS OF PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S122
Product code
NVZ
Decision date
2006-07-11
Classification
Pulse Generator, Permanent, Implantable
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
VARIOUS MODELS OF PACEMAKERS
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S122
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.