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 | PROTECTA/PROTECTA XT CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 coral sea street n.e. mounds view, MN 55112 |
PMA Number | P010031 |
Supplement Number | S256 |
Date Received | 05/13/2011 |
Decision Date | 06/10/2011 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE THE CLEANING AREA OF THE DEVICES. |
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