PMA P150012S033

Device
Torque Wrench
Applicant
Boston Scientific
PMA number
P150012
Supplement
S033
Product code
LWP
Decision date
2017-09-11
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
Approval for updates to the torque wrench tool.

Current openFDA PMA Record#

Device
Torque Wrench
Applicant
Boston Scientific
PMA number
P150012
Supplement
S033
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2017-09-11
Decision code
APPR
Date received
2017-07-17
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for updates to the torque wrench tool.