|
Device | Rotablator® Rotational Atherectomy System |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S160 |
Date Received | 04/13/2017 |
Decision Date | 05/12/2017 |
Product Code |
MCX |
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 Sterilization of devices within the scope of this bundled submission with the optimized BSC2000-2 cycle in Chamber 3 at the Synergy Health/Steris, Costa Rica facility. |