|
Device | Dynagen, Inogen, Origen Implantable Cardiac Defibrillators (ICDs) |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S368 |
Date Received | 03/23/2016 |
Decision Date | 04/14/2016 |
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 Update work instructions for the manufacturing inspection process to define acceptable criteria for a cosmetic defect in high voltage capacitors. |