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 | INSYNC II PROTECT ICD, IIIMARQUIS ICD, MARQUIS ICD, MAXIMO ICD, BRAVA CRT-D, CONCERTO ICD, II CRT-D, CONSULTA ICD, MAXIM |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S397 |
Date Received | 08/23/2013 |
Decision Date | 02/14/2014 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR UPDATES TO THE MEDTRONIC MYCARELINK PATIENT MONITOR MODEL24950, READER MODEL 24955, AND ACCESSORIES, MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA) AND APPLICATION SOFTWARE SW026 TO SUPPORT MEDTRONIC¿S REVEAL LINQ INSERTABLE CARDIAC MONITORS (ICM). |
Approval Order | Approval Order |
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