PMA P910077S086

Device
ZOOM LATITUDE PROGRAMMING SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S086
Product code
LWS
Decision date
2008-05-09
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
ADDITIONAL SUPPLIER FOR A COMPONENT (TOUCH SCREEN) USED IN THE MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM.

Current openFDA PMA Record#

Device
ZOOM LATITUDE PROGRAMMING SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S086
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2008-05-09
Decision code
OK30
Date received
2008-04-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITIONAL SUPPLIER FOR A COMPONENT (TOUCH SCREEN) USED IN THE MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM.