FDA.reportPublic FDA data

PMA P960040S418

Device
Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Perciva
Applicant
Boston Scientific
PMA number
P960040
Supplement
S418
Product code
LWS
Decision date
2018-03-26
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval for a Software Maintenance Release (SMR) for the Model 3922 Pacing System Analyzer (PSA) Software Application that functions within Model 3300 LATITUDE Programming System (LPS).

Current openFDA PMA Record#

Device
Teligen, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant, Perciva
Applicant
Boston Scientific
PMA number
P960040
Supplement
S418
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2018-03-26
Decision code
APPR
Date received
2018-01-18
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a Software Maintenance Release (SMR) for the Model 3922 Pacing System Analyzer (PSA) Software Application that functions within Model 3300 LATITUDE Programming System (LPS).