PMA P010012S271

Device
TELIGEN ICD MODELS E102, E103, E110, E111
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S271
Product code
LWP
Decision date
2011-09-15
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
ALTERNATE SUPPLIERS FOR CERAMIC CAPACITORS.

Current openFDA PMA Record#

Device
TELIGEN ICD MODELS E102, E103, E110, E111
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S271
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2011-09-15
Decision code
OK30
Date received
2011-08-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SUPPLIERS FOR CERAMIC CAPACITORS.