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 | STELIX II EASY TURN LEAD MODELS BRF24D, BRF25D, BRF26D |
Generic Name | Permanent defibrillator electrodes |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P020030 |
Supplement Number | S003 |
Date Received | 05/25/2006 |
Decision Date | 07/12/2006 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE HELIX MECHANISM, ADDITION OF RADIOPAQUE MARKERS, AND MODIFICATIONS TO THE DEVICE INSPECTION PROCEDURES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STELIX II EASY TURN MODELS BRF24D, BRF25D, AND BRF26D AND ARE DESIGNED TO BE USED WITH AN IMPLANTABLE PACEMAKER FOR PACING AND SENSING OF THE HEART. |
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