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 | SMARTMAGNET(TM) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S013 |
Date Received | 08/30/2000 |
Decision Date | 02/22/2001 |
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 FOR THE MODEL 9322 SMARTMAGNET(TM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTMAGNET(TM) AND IS INDICATED FOR KEEPING MEDTRONIC ICDS FROM DELIVERING INAPPROPRIATE THERAPY, SUCH AS SHOCKS, TO PATIENTS DURING SURGICAL PROCEDURES THAT REQUIRE CAUTERY OR OTHER ELECTRICALLY NOISY DEVICES. |
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