PMA P910077S095

Device
MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S095
Product code
LWS
Decision date
2009-07-06
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
ADDITION OF A NEW SUPPLIER FOR THE DSUB COMPONENT AND SPECIFICATION CHANGES TO THE COMPONENT.

Current openFDA PMA Record#

Device
MODEL 3120 ZOOM LATITUDE PROGRAMMING SYSTEM
Applicant
Boston Scientific
PMA number
P910077
Supplement
S095
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2009-07-06
Decision code
OK30
Date received
2009-06-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW SUPPLIER FOR THE DSUB COMPONENT AND SPECIFICATION CHANGES TO THE COMPONENT.