|
Device | THERMACOOL SF BI-DIRECTIONAL AND UNI-DIRECTIONAL CATHETERS |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S038 |
Date Received | 01/23/2012 |
Decision Date | 03/23/2012 |
Product Codes |
OAD OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR EXTENDING THE SHELF LIFE FOR THE CATHETERS REFERENCED FROM ONE TO THREE YEARS. |
Post-Approval Study | Show Report Schedule and Study Progress |