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 StarFix Lead |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P060039 |
Supplement Number | S096 |
Date Received | 09/16/2019 |
Decision Date | 09/27/2019 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Transfer of receiving and incoming inspection activities from Medtronic Rice Creek facility to the Medtronic Puerto Rico Operations Company (MPROC) Villalba, MPROC Juncos, and the Federal Express/Third Party Logistics facility in Guaynabo, Puerto Rico. |
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