PMA P910077S135

Device
LATITUDE COMMUNICATOR
Applicant
Boston Scientific
PMA number
P910077
Supplement
S135
Product code
LWS
Decision date
2013-06-20
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
ALTERNATE SURFACE MOUNT TECHNOLOGY (SMT) LINE FOR PRODUCTION OF PRINTED CIRCUIT BOARD ASSEMBLIES.

Current openFDA PMA Record#

Device
LATITUDE COMMUNICATOR
Applicant
Boston Scientific
PMA number
P910077
Supplement
S135
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2013-06-20
Decision code
OK30
Date received
2013-05-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SURFACE MOUNT TECHNOLOGY (SMT) LINE FOR PRODUCTION OF PRINTED CIRCUIT BOARD ASSEMBLIES.