PMA P910077S098

Device
MODEL 6476 G2 RF LATITUDE COMMUNICATOR
Applicant
Boston Scientific
PMA number
P910077
Supplement
S098
Product code
LWS
Decision date
2009-11-16
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
CHANGE IN THE SOLDERING PROCESS.

Current openFDA PMA Record#

Device
MODEL 6476 G2 RF LATITUDE COMMUNICATOR
Applicant
Boston Scientific
PMA number
P910077
Supplement
S098
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2009-11-16
Decision code
OK30
Date received
2009-10-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE SOLDERING PROCESS.