|
Device | Celsius, Celsius RMT, EZ Steer Bi-directional non nav |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S077 |
Date Received | 03/02/2021 |
Decision Date | 04/07/2021 |
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 the addition of warnings from other catheter lines and the clarification of existing warnings and instructions. |