|
Device | THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P040036 |
Supplement Number | S047 |
Date Received | 10/30/2014 |
Decision Date | 11/19/2014 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR LABELING CHANGES. |