|
Device | SAFIRE DUO AND COOL PATH DUO ABLATION CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Abbott Medical 2375 MORSE AVENUE Plymouth, MN 55442 |
PMA Number | P110016 |
Supplement Number | S014 |
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. |