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 | ASSURANT COBALT BALLOON LLIAC BALLOON-EXPANDABLE STENT SYSTEM |
Generic Name | STENT, ILIAC |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P110011 |
Supplement Number | S001 |
Date Received | 11/14/2011 |
Decision Date | 12/07/2011 |
Withdrawal Date
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01/22/2020 |
Product Code |
NIO |
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 CHANGING THE PRODUCT PRINT INFORMATION FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS. |
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