PMA P010012S172

Device
EASYTRAK 2
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S172
Product code
LWP
Decision date
2008-02-25
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
ADDITION OF AN INSPECTION.

Current openFDA PMA Record#

Device
EASYTRAK 2
Applicant
Boston Scientific Corp
PMA number
P010012
Supplement
S172
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2008-02-25
Decision code
OK30
Date received
2008-02-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN INSPECTION.