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 | BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO ICD, CONCERTO II CRT-D, CONSULTA CRT-D, INSYNC II PROTECT ICD, INSYNC III MARQUI |
Generic Name | Pacemaker/icd/crt non-implanted components |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S464 |
Date Received | 08/27/2014 |
Decision Date | 11/07/2014 |
Product Code |
OSR |
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 THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES. |
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