|
Device | AngioJet Ultra XMI / Spiroflex / Spiroflex VG / Distaflex Thrombectomy Set |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S066 |
Date Received | 07/18/2017 |
Decision Date | 10/16/2017 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for design and processing changes to the outlet adapter assembly for the Angiojet Thrombectomy Sets. |