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 | SYNCHROMED2 PUMP FEED-THROUGHS & CATHETER ACCESSORIES |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S128 |
Date Received | 05/06/2010 |
Decision Date | 12/03/2010 |
Product Code |
LKK |
Advisory Committee |
General Hospital |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE INTRODUCER NEEDLE TIP, NEEDLE HUB, AND STYLET CAP MATERIALS FOR THE INTRODUCER NEEDLE USED WITH THE MODELS 8709, 8709SC, 8711 AND 8731SC INTRATHECAL CATHETERS AND MODEL 8598A REVISION KIT. |
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