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 | THERAPY COOL PATH ABLATION CATHETER |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P060019 |
Supplement Number | S013 |
Date Received | 08/30/2010 |
Decision Date | 12/03/2010 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CHANGE THE MATERIAL OF THE EXTENSION TUBE TO INCREASE THE TORQUE RESISTANCE OF THE EXTENSION TUBE DURING HANDLE MANIPULATION. THE MATERIAL OF THE EXTENSION TUBE WILL BE CHANGED FROM A NON-BRAIDED PELLETHANE TO A PEBAX BRAIDED TUBE (72D). ADDITIONALLY, THE LENGTH OF THE EXTENSION TUBE AND THE INTERNAL FLUID LUMEN TUBE WILL BE DECREASED FROM 11 CM TO 4 CM. |
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