PMA P960040S398

Device
Torque Wrench
Applicant
Boston Scientific
PMA number
P960040
Supplement
S398
Product code
LWS
Decision date
2017-09-11
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (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
P960040
Supplement
S398
Product code
LWS
Generic name
Implantable cardioverter defibrillator (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.