|
Device | NAVISTAR RMT CATHETER FAMILY |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S012 |
Date Received | 10/09/2008 |
Decision Date | 11/07/2008 |
Product Code |
LPB |
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 TWO ADDITIONAL QUALITY CONTROL INSPECTION STEPS: 1) ADDING A 100% VISUAL INSPECTION OF THE PCB BOARDS TO VERIFY THAT ALL COMPONENTS ARE PRESENT, AND 2) ADDING AN EEPROM READ STEP DURING THE EXISTING CALIBRATION PROCESS TO VERIFY THAT ALL PCB COMPONENTS ARE PRESENT AND FUNCTIONING PROPERLY. |