|
Device | THERAPY COOL PATH ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P060019 |
Supplement Number | S030 |
Date Received | 11/07/2014 |
Decision Date | 07/09/2015 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES. |