|
Device | SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) |
Generic Name | Coronary drug-eluting stent |
Applicant | BOSTON SCIENTIFIC CORPORATION One Scimed Place Maple Grove, MN 55311 |
PMA Number | P150003 |
Supplement Number | S051 |
Date Received | 07/12/2019 |
Decision Date | 08/09/2019 |
Product Code |
NIQ |
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 Alternate process to automate top assembly process steps for the manufacture of stent delivery catheters. |