|
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 | S025 |
Date Received | 11/13/2023 |
Decision Date | 12/12/2023 |
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 changes to the sterilization Chamber 9 Programmable Logic Controller at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility |