|
Device | Ranger™ Paclitaxel-Coated PTA 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 | S026 |
Date Received | 11/17/2023 |
Decision Date | 11/24/2023 |
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 use of an alternate supplier for a Tyvek header bag |