PMA P910077S169

Device
LATITUDE Programming System
Applicant
Boston Scientific
Product code
LWS
Decision date
2019-07-08
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval for changes to the printed circuit board assembly in the Model 3300 LATITUDE Programming System.

Current openFDA PMA Record#

Device
LATITUDE Programming System
Applicant
Boston Scientific
PMA number
P910077
Supplement
S169
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2019-07-08
Decision code
APPR
Date received
2019-02-27
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to the printed circuit board assembly in the Model 3300 LATITUDE Programming System.