PMA P010012S122

Device
CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S122
Product code
LWP
Decision date
2006-04-26
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
ALTERNATIVE SUPPLIERS FOR THE CONNECTOR BLOCKS AND SET SCREWS.

Current openFDA PMA Record#

Device
CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S122
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2006-04-26
Decision code
OK30
Date received
2006-03-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATIVE SUPPLIERS FOR THE CONNECTOR BLOCKS AND SET SCREWS.