FDA.reportPublic FDA data

PMA P110042S144

Device
EMBLEM S-ICD Programmer
Applicant
Boston Scientific Corporation
Product code
LWS
Decision date
2020-09-17
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Implement new flux and solder materials for use in the manufacture of the Model 3300 LATITUDE Programming System, Model 6395 Telemetry Wand, and Model 3200 EMBLEM S-ICD Programmer as part of the manufacturing process.

Current openFDA PMA Record#

Device
EMBLEM S-ICD Programmer
Applicant
Boston Scientific Corporation
PMA number
P110042
Supplement
S144
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2020-09-17
Decision code
OK30
Date received
2020-08-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implement new flux and solder materials for use in the manufacture of the Model 3300 LATITUDE Programming System, Model 6395 Telemetry Wand, and Model 3200 EMBLEM S-ICD Programmer as part of the manufacturing process.