|
Device | EluNIR™ 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 | S002 |
Date Received | 02/21/2018 |
Decision Date | 04/17/2018 |
Product Code |
NIQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the addition of two new balloon manufacturing machines. |