|
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 | S030 |
Date Received | 06/27/2012 |
Decision Date | 09/27/2012 |
Product Code |
NIN |
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 MODIFIED CONFIGURATION OF THE CARRIER COIL USED IN PRODUCT PACKAGING. |