PMA P910077S131

Device
LATITUDE PATIENT MANAGEMENT SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S131
Product code
LWS
Decision date
2013-04-30
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE MODEL 6430 AC POWER ADAPTER.

Current openFDA PMA Record#

Device
LATITUDE PATIENT MANAGEMENT SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S131
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2013-04-30
Decision code
APPR
Date received
2013-02-08
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE MODEL 6430 AC POWER ADAPTER.