|
Device | ORIGEN CRT-D; ORIGEN X4 CRT-D; INOGEN CRT-D; INOGEN X4 CRT-D; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; AUTOGEN CRT-D; MOMENTUM C |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S547 |
Date Received | 10/08/2021 |
Decision Date | 10/21/2021 |
Product Code |
NIK |
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 Automate a battery component cleaning process. |