|
Device | ROTAWIRE FLOPPY GOLD GUIDE WIRE |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S078 |
Date Received | 09/12/2003 |
Decision Date | 10/22/2003 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE ROTAWIRE GOLD PLATING MANUFACTURING EQUIPMENT AND MONITORING. |