|
Device | MAESTRO 3000 CARDIAC ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 150 BAYTECH DRIVE SAN JOSE, CA 95134 |
PMA Number | P980003 |
Supplement Number | S045 |
Date Received | 10/31/2013 |
Decision Date | 12/05/2013 |
Withdrawal Date
|
02/28/2024 |
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, INCLUDING UPDATES IN ACCORDANCE WITH IEC 60601-1 THIRD EDITION. |