PMA P940031S063

Device
VIGOR DR/SR/DISCOVER/MERIDIAN
Applicant
Boston Scientific
PMA number
P940031
Supplement
S063
Product code
LWP
Decision date
2008-07-02
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
REMOVAL OF CERTAIN ELECTRICAL TESTING FOR CAPACITORS DURING INCOMING INSPECTION ACTIVITIES.

Current openFDA PMA Record#

Device
VIGOR DR/SR/DISCOVER/MERIDIAN
Applicant
Boston Scientific
PMA number
P940031
Supplement
S063
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2008-07-02
Decision code
OK30
Date received
2008-06-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REMOVAL OF CERTAIN ELECTRICAL TESTING FOR CAPACITORS DURING INCOMING INSPECTION ACTIVITIES.