PMA P010012S107

Device
CONTAK CD FAMILY
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S107
Product code
LWP
Decision date
2006-03-31
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
MOVING THE PROCESS OF APPLYING POLYIMIDE OVER THE BRAZED JOINTS FROM GUIDANT TO THE TELEMETRY COIL SUPPLIER.

Current openFDA PMA Record#

Device
CONTAK CD FAMILY
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S107
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2006-03-31
Decision code
OK30
Date received
2006-03-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MOVING THE PROCESS OF APPLYING POLYIMIDE OVER THE BRAZED JOINTS FROM GUIDANT TO THE TELEMETRY COIL SUPPLIER.