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 | INTRATHECAL CATHETER MODELS 8709, 8711, 8709SC, 8731SC, AND REVISION KIT 8598A |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S088 |
Date Received | 11/08/2006 |
Decision Date | 05/01/2007 |
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 | Yes |
Approval Order Statement APPROVAL FOR: 1) A NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 2) A MODIFIED MANUFACTURING MONITORING PROCESS TO ASSURE CONFORMANCE TO NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 3) A CHANGE TO THE CATHETER TIP MATERIAL FOR CATHETER MODEL 8731SC AND REVISION KIT MODEL 8598A; AND 4) LABELING REVISIONS. |
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