|
Device | LATITUDE Programming System (Programmer) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S181 |
Date Received | 08/24/2020 |
Decision Date | 09/17/2020 |
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 Implement new flux and solder materials for use in the manufacture of the Model 3300 LATITUDE Programming System, Model 6395 Telemetry Wand, and Model 3200 EMBLEM S-ICD Programmer as part of the manufacturing process. |