|
Device | EluNIR-PERLTM Ridaforolimus Eluting Coronary Stent System |
Generic Name | Coronary drug-eluting stent |
Applicant | Medinol, Ltd. Kiryat Atidim, Bldg. 8 POB 58165 Tel Aviv 61581 |
PMA Number | P170008 |
Supplement Number | S047 |
Date Received | 11/09/2023 |
Decision Date | 12/08/2023 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement to modify the Limulus Amebocyte Lysate (LAL) and bioburden lot testing requirements |