PMA P910077S147

Device
LATITUDE CONSULT SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S147
Product code
OSR
Decision date
2014-11-06
Classification
Pacemaker/icd/crt Non-implanted Components
Generic name
Pacemaker/icd/crt non-implanted components
Approval order statement
APPROVAL FOR THE LATITUDE CONSULT SYSTEM RELEASE 1.01 WHICH INCLUDES THE COMMUNICATOR MODEL 6299 AND APPLICATION SOFTWARE SERVER MODEL 6294.

Current openFDA PMA Record#

Device
LATITUDE CONSULT SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S147
Product code
OSR
Generic name
Pacemaker/icd/crt non-implanted components
Decision date
2014-11-06
Decision code
APPR
Date received
2014-09-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE LATITUDE CONSULT SYSTEM RELEASE 1.01 WHICH INCLUDES THE COMMUNICATOR MODEL 6299 AND APPLICATION SOFTWARE SERVER MODEL 6294.