|
Device | REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P130030 |
Supplement Number | S017 |
Date Received | 09/25/2015 |
Decision Date | 02/16/2016 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to add an alternate component supplier. |