PMA P910077S138

Device
LATTITUDE CONSULT SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S138
Product code
OSR
Decision date
2014-03-20
Classification
Pacemaker/icd/crt Non-implanted Components
Generic name
Pacemaker/icd/crt non-implanted components
Approval order statement
APPROVAL FOR THE LATITUDE CONSULT SYSTEM WHICH INCLUDES THE COMMUNICATOR MODEL 6299 AND APPLICATION SOFTWARE SERVER MODEL 6294.

Current openFDA PMA Record#

Device
LATTITUDE CONSULT SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S138
Product code
OSR
Generic name
Pacemaker/icd/crt non-implanted components
Decision date
2014-03-20
Decision code
APPR
Date received
2013-09-25
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE LATITUDE CONSULT SYSTEM WHICH INCLUDES THE COMMUNICATOR MODEL 6299 AND APPLICATION SOFTWARE SERVER MODEL 6294.