PMA P910077S093

Device
LATITUDE INDUCTIVE COMMUNICATOR
Applicant
Boston Scientific
PMA number
P910077
Supplement
S093
Product code
LWS
Decision date
2009-04-28
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481, VERSION 1.5.

Current openFDA PMA Record#

Device
LATITUDE INDUCTIVE COMMUNICATOR
Applicant
Boston Scientific
PMA number
P910077
Supplement
S093
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2009-04-28
Decision code
APPR
Date received
2009-03-16
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR CHANGES TO THE LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481, VERSION 1.5.