PMA P910077S075

Device
LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR
Applicant
Boston Scientific
PMA number
P910077
Supplement
S075
Product code
LWS
Decision date
2007-08-03
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRICAL ASSEMBLY, BUFFALO GROVE, ILLINOIS.

Current openFDA PMA Record#

Device
LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR
Applicant
Boston Scientific
PMA number
P910077
Supplement
S075
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2007-08-03
Decision code
APPR
Date received
2007-05-24
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS ELECTRICAL ASSEMBLY, BUFFALO GROVE, ILLINOIS.