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 | MEDTRONIC MODELS 8616-10 & 8617-10(ALSO REFERRED TO AS MODELS 8631 & 8635) SYNCHROMED(R) IMPLANT.PROGRAM. INFUSION PUMP |
Generic Name | Pump, infusion, implanted, programmable |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S022 |
Date Received | 09/13/1991 |
Decision Date | 07/29/1996 |
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 (1) THE 10 CC SYNCHROMED IMPLANTABLE PROGRAMMABLE INFUSION PUMP, MODELS 8616-10 AND 8617-10 FOR USE IN THE PEDIATRIC AND ADULT POPULATION FOR THE INTRATHECAL DELIVERY OF LIORESAL INTRATHECAL (BACLOFEN INJECTION( FOR THE MANAGEMENT OF SEVERE SPASTICITY OF SPINAL AND CEREBRAL ORIGIN, AND (2) TO CHANGE THE INDICATIONS FOR THE INTRATHECAL DELIVERY OF LIORESAL INTRATHECAL (BACLOFEN INJECTION) FOR THE 18 CC RESERVOIR SYNCHROMED IMPLANTABLE, PROGRAMMABLE INFUSION PUMPS, MODELS 8616-18, 8617-18, 8617L-18, 8618-18, AND 8618L-18 TO INCLUDE SEVERE SPASTICITY OF CEREBRAL ORIGIN |
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