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. |
|
Device | THERAPY COOL FLEX ABLATION CATHETER |
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 | S008 |
Date Received | 04/01/2013 |
Decision Date | 12/18/2013 |
Product Code |
OAD |
Docket Number | 13M-1693 |
Notice Date | 01/15/2014 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01408485
|
Supplement Type | Panel Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE THERAPY COOL FLEX ABLATION CATHETER. THIS DEVICE IS INDICATED FOR USE WITH THE COMPATIBLE IRRIGATION PUMP AND 1500T9-CP RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
|
|