Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | SAFIRE BLU DUO SP ABLATION CATHETERS |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | Abbott Medical 2375 MORSE AVENUE Plymouth, MN 55442 |
PMA Number | P110016 |
Supplement Number | S002 |
Date Received | 05/11/2012 |
Decision Date | 07/10/2012 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATIVE PACKAGE CONFIGURATION FOR THE SUBJECT ABLATION CATHETERS. THE NEW PACKAGE CONFIGURATION WOULD CHANGE THE PREVIOUS COILED TRAY CONFIGURATION TO A TRAY WITH A STRAIGHT CONFIGURATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SAFIRE BLU SP IRRIGATED ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER, AND SAFIRE BLU DUO SP ABLATION CATHETER. |
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