FDA.reportPublic FDA data

PMA P150012S052

Device
Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI
Applicant
Boston Scientific
PMA number
P150012
Supplement
S052
Product code
LWP
Decision date
2018-03-26
Classification
Implantable Pulse Generator, Pacemaker (non-crt)
Generic name
Implantable pulse generator, pacemaker (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
Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, Accolade MRI
Applicant
Boston Scientific
PMA number
P150012
Supplement
S052
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (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).