|
Device | CELSIUS THERMOCOOL & 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 | S027 |
Date Received | 02/12/2010 |
Decision Date | 03/12/2010 |
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 THERMISTOR TEMPERATURE SENSOR USED IN THE MANUFACTURE OF ABLATION CATHETERS. |
Post-Approval Study | Show Report Schedule and Study Progress |