|
Device | NG3 Implantable Cardioverter Defibrillators (ICDs), NG4 ICDs |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S491 |
Date Received | 04/17/2023 |
Decision Date | 05/11/2023 |
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 Updates to the header inspection performed during the Header Overmolding process to identify material discontinuities. |