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 | ATTAIN BIPOLAR OTW LEAD, ATTAIN OTW LV LEAD, CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P |
Generic Name | pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) |
Applicant | MEDTRONIC Inc. 8200 coral sea street ne ms mv s11 mounds view, MN 55112 |
PMA Number | P010015 |
Supplement Number | S290 |
Date Received | 12/28/2015 |
Decision Date | 01/25/2016 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES. |
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