PMA P010012S251

Device
LIVIAN & RENEWAL 3 PULSE GENERATORS
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S251
Product code
LWP
Decision date
2010-09-14
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
CHANGE TO THE THERMODE BLADE WING.

Current openFDA PMA Record#

Device
LIVIAN & RENEWAL 3 PULSE GENERATORS
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S251
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2010-09-14
Decision code
OK30
Date received
2010-08-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE TO THE THERMODE BLADE WING.