|
Device | NAVISTAR RMT THERMOCOOL CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S024 |
Date Received | 01/14/2010 |
Decision Date | 06/28/2010 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A TEST METHOD CHANGE FOR THE FINAL INSPECTION FLOW AND LEAK TEST. |