PMA P910023S134

Device
CADENCE FAMILY OF ICD'S
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S134
Product code
NVZ
Decision date
2007-05-07
Classification
Pulse Generator, Permanent, Implantable
Generic name
Pulse generator, permanent, implantable
Approval order statement
APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.

Current openFDA PMA Record#

Device
CADENCE FAMILY OF ICD'S
Applicant
ABBOTT MEDICAL
PMA number
P910023
Supplement
S134
Product code
NVZ
Generic name
Pulse generator, permanent, implantable
Decision date
2007-05-07
Decision code
APPR
Date received
2007-04-13
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE MODEL 3330 VERSION 6.1.0 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.4.0 SOFTWARE FOR THE MODEL 3510 PROGRAMMER.