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 | ASCENDA INTRATHECAL CATHETER |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S175 |
Date Received | 08/28/2012 |
Decision Date | 01/07/2013 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MINOR DESIGN CONTROL CHANGE, AND SUBSEQUENT MANUFACTURING PROCESS CHANGES, TO REMOVE THE LACK OF LAMINATION NOTE FROM THE PUMP AND SPINAL CATHETER SEGMENTS ASSEMBLY LEVEL PRINTS FOR THE DEVICE. |
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