|
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 | S116 |
Date Received | 06/06/2012 |
Decision Date | 07/06/2012 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement REMOVAL OF AN IN-PROCESS PULL TEST AND INTRODUCTION OF A START OF SHIFT EQUIPMENT VERIFICATION. |