|
Device | CELSIUS THERMOCOOL/CELSIUS RMT THERMOCOOL/NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCOOL/NAV CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S035 |
Date Received | 08/29/2011 |
Decision Date | 10/07/2011 |
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 |
Approval Order Statement PARAMETRIC RELEASE OF STERILIZED PRODUCT USING ETHYLENE OXIDE. |