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 | CELSIUS FLTR CATHETER UNIDIRECTIONAL, CELSIUS FLTR CATHETER BIDIRECTIONAL |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | Biosense Webster, Inc 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P950005 |
Supplement Number | S047 |
Date Received | 11/01/2013 |
Decision Date | 01/22/2014 |
Product Code |
OAD |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MANUFACTURING AND DESIGN CHANGES TO THE CATHETER TIP. |
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