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 | ISOFLEX S LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960030 |
Supplement Number | S016 |
Date Received | 03/05/2007 |
Decision Date | 05/09/2007 |
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 LEAD INSULATION WALL THICKNESS AND LENGTH, AS WELL AS A CHANGE TO THE OUTER COIL EXIT ANGLE. |
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