|
Device | WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S001 |
Date Received | 11/10/1997 |
Decision Date | 05/07/1998 |
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 the 6 Fr and 7 Fr Cordis Webster Diagnostic/Ablation Deflectable Tip Catheters - Thermistor and Non-Temperature Sensing Model and Interface Cables used with the EP Technologies 1000 RF Generator. |