|
Device | EZ STEER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S057 |
Date Received | 09/13/2013 |
Decision Date | 10/09/2013 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ADDITION OF AN ALTERNATE SUPPLIER FOR THE EXTRUSION AND BRAIDING PROCESS FOR THE FAMILY OF PRODUCTS. |
Post-Approval Study | Show Report Schedule and Study Progress |