|
Device | NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ STEER THERMOCOOL NAV |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S026 |
Date Received | 02/05/2010 |
Decision Date | 03/04/2010 |
Product Code |
LPB |
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 ADDITION OF AN ALTERNATE SUPPLIER FOR THE MU-SHIELD USED IN THE MANUFACTURE OF THE NAVIGATIONAL CATHETERS. |