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Device | ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S041 |
Date Received | 02/03/2014 |
Decision Date | 03/05/2014 |
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 MODIFICATION TO CHANGE THE CURRENT MANUAL METHOD OF QUANTIFYING THE AMOUNT OF BACTERIAL ENDOTOXINS PRESENT TO USING AN AUTOMATED INSTRUMENT. ADDITIONALLY, THE NUMBER OF SAMPLES COLLECTED WILL BE CHANGED TO THREE SAMPLES PER STERILE LOAD, TESTED ON A POOLED BASIS AND WITH EXPLICIT EXTRACTION INSTRUCTIONS. |