PMA P030054S021

Device
QUICKSITE MODEL 1056K LEAD
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S021
Product code
NIK
Decision date
2006-02-24
Classification
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement
CHANGE IN VENDORS FOR THE TUBING MATERIAL.

Current openFDA PMA Record#

Device
QUICKSITE MODEL 1056K LEAD
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S021
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date
2006-02-24
Decision code
OK30
Date received
2006-01-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN VENDORS FOR THE TUBING MATERIAL.