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 | SYNCHROMED II PUMP |
Generic Name | pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 central avenue ne minneapolis, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S159 |
Date Received | 09/23/2011 |
Decision Date | 11/10/2011 |
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 MINOR CHANGES TO THE DIMENSIONAL SPECIFICATIONS OF THE SYNCHRO MED II PUMP TUBE ASSEMBLY COMPONENT. |
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