PMA P030054S179

Device
MERLIN 3650 PROGRAMMER
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S179
Product code
NIK
Decision date
2011-01-07
Classification
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement
ALTERNATE SUPPLIER FOR THE PRINTED CIRCUIT BOARD (PCB) USED IN THE MERLIN 3650 PROGRAMMER.

Current openFDA PMA Record#

Device
MERLIN 3650 PROGRAMMER
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S179
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2011-01-07
Decision code
OK30
Date received
2010-12-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SUPPLIER FOR THE PRINTED CIRCUIT BOARD (PCB) USED IN THE MERLIN 3650 PROGRAMMER.