PMA P910077S107

Device
LATITUDE COMMUNICATORS & PROGRAMMER
Applicant
Boston Scientific
PMA number
P910077
Supplement
S107
Product code
LWS
Decision date
2010-09-29
Classification
Implantable Cardioverter Defibrillator (non-crt)
Generic name
Implantable cardioverter defibrillator (non-CRT)
Approval order statement
NEW SOLDERING EQUIPMENT AND SITE RELOCATION FOR PRINTED CIRCUIT BOARDS SUPPLIER.

Current openFDA PMA Record#

Device
LATITUDE COMMUNICATORS & PROGRAMMER
Applicant
Boston Scientific
PMA number
P910077
Supplement
S107
Product code
LWS
Generic name
Implantable cardioverter defibrillator (non-CRT)
Decision date
2010-09-29
Decision code
OK30
Date received
2010-07-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
NEW SOLDERING EQUIPMENT AND SITE RELOCATION FOR PRINTED CIRCUIT BOARDS SUPPLIER.