|
Device | Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P190019 |
Supplement Number | S023 |
Date Received | 09/07/2023 |
Decision Date | 10/05/2023 |
Product Code |
ONU |
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 Introduce additional endotoxin test laboratories. |