|
Device | Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S179 |
Date Received | 10/10/2019 |
Decision Date | 11/07/2019 |
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 Reduce the Ethylene Oxide gas concentration and qualify additional process challenge devices used in the BSC2000-2 sterilization cycle. |