|
Device | LATITUDE/PROGRAMMER/RECORDER/MONITOR |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S128 |
Date Received | 10/15/2012 |
Decision Date | 11/14/2012 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MOVING PRODUCTION OF VARIOUS PRINTED CIRCUIT BOARD ASSEMBLIES TO NEW MANUFACTURING LINES AND AN ALTERNATE WATER WASH SYSTEM AT A SUPPLIER LOCATION. |