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 IMPLANTABLE INFUSION SYSTEM |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S070 |
Date Received | 03/31/2005 |
Decision Date | 09/26/2005 |
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 | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MODEL 8832 PERSONAL THERAPY MANAGER (PTM), AN ACCESSORY TO THE SYNCHROMED II IMPLANTABLE INFUSION SYSTEM, INDICATED FOR THE PATIENT TO ACTIVATE DELIVERY OF PHYSICIAN PROGRAMMED SUPPLEMENTAL DOSES OF PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION FROM THE SYNCHROMED II PUMP FOR THE TREATMENT OF CHRONIC INTRACTABLE PAIN. |
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