|
Device | EZ STEER AND EZ STEER DS BIDIRECTIONAL DIAGNOSTIC/ABLATION CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S019 |
Date Received | 09/06/2005 |
Decision Date | 08/29/2006 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR USING A NEW HANDLE AND PULLER WIRES. |