|
Device | EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S067 |
Date Received | 02/20/2015 |
Decision Date | 03/23/2015 |
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 ADDING A SECOND SUPPLIER FOR THE 1MM SENSOR COMPONENT USED IN THE CATHETER FAMILIES. |