PMA P910077S061

Device
LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481
Applicant
Boston Scientific
PMA number
P910077
Supplement
S061
Product code
LWS
Decision date
2006-08-08
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR & SOFTWARE V1.2.0 AND REGULATED APPLICATION SERVER (RAS) V2.0.3.

Current openFDA PMA Record#

Device
LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481
Applicant
Boston Scientific
PMA number
P910077
Supplement
S061
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2006-08-08
Decision code
APPR
Date received
2006-04-18
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR & SOFTWARE V1.2.0 AND REGULATED APPLICATION SERVER (RAS) V2.0.3.