|
Device | EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM |
Generic Name | STENT, RENAL |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P060006 |
Supplement Number | S053 |
Date Received | 12/30/2013 |
Decision Date | 01/29/2014 |
Product Code |
NIN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REMOVE THE METALS CONTENT LOAD TEST USED FOR THE MONITORING OF ELECTROPOLISHING SOLUTIONS. |
Post-Approval Study | Show Report Schedule and Study Progress |