FDA.reportPublic FDA data

PMA P910077S165

Device
Latitude Programming System
Applicant
Boston Scientific
PMA number
P910077
Supplement
S165
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 the Model 3300 LATITUDE Programming System (LPS).

Current openFDA PMA Record#

Device
Latitude Programming System
Applicant
Boston Scientific
PMA number
P910077
Supplement
S165
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 the Model 3300 LATITUDE Programming System (LPS).