PMA P110042S083

Device
S-ICD (Subcutaneous-ICD) Telemetry Wand
Applicant
Boston Scientific Corporation
PMA number
P110042
Supplement
S083
Product code
LWS
Decision date
2017-09-11
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
Approval for the Model 3300 LATITUDE Programming System.

Current openFDA PMA Record#

Device
S-ICD (Subcutaneous-ICD) Telemetry Wand
Applicant
Boston Scientific Corporation
PMA number
P110042
Supplement
S083
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2017-09-11
Decision code
APPR
Date received
2017-04-03
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the Model 3300 LATITUDE Programming System.