|
Device | NAVISTAR THERMOCOOL |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S054 |
Date Received | 07/15/2013 |
Decision Date | 08/22/2013 |
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 A SECOND SOURCE SUPPLIER FOR THE MANUFACTURING OF TIP ELECTRODES FOR THE FAMILY OF PRODUCTS. |
Post-Approval Study | Show Report Schedule and Study Progress |