|
Device | NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), NG4 CRT-Ds |
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 | S568 |
Date Received | 04/17/2023 |
Decision Date | 05/11/2023 |
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 Updates to the header inspection performed during the Header Overmolding process to identify material discontinuities. |