PMA P940031S062

Device
VIGOR DR/SR/DISCOVER/MERIDIAN/PDP
Applicant
Boston Scientific
PMA number
P940031
Supplement
S062
Product code
LWP
Decision date
2007-12-05
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
CHANGES TO THE SEAL PLUG BONDING CURING PROCESS.

Current openFDA PMA Record#

Device
VIGOR DR/SR/DISCOVER/MERIDIAN/PDP
Applicant
Boston Scientific
PMA number
P940031
Supplement
S062
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2007-12-05
Decision code
OK30
Date received
2007-11-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES TO THE SEAL PLUG BONDING CURING PROCESS.