PMA P030054S225

Device
MERLIN PATIENT CARE SYSTEM ACCESSORIES
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S225
Product code
NIK
Decision date
2012-08-08
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 ECG CABLES.

Current openFDA PMA Record#

Device
MERLIN PATIENT CARE SYSTEM ACCESSORIES
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S225
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2012-08-08
Decision code
OK30
Date received
2012-07-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SUPPLIER FOR ECG CABLES.