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 | ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432 |
PMA Number | P840001 |
Supplement Number | S053 |
Date Received | 04/16/2001 |
Decision Date | 08/06/2001 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE MODEL 7495 AND MODEL 7495LZ EXTENSIONS. THE FICILITY IS LOCATED AT MEDTRONIC NEUROLOGICAL PUERTO RICO OPERATIONS, VILLALBA, PUERTO RICO. |
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