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 ITREL(R) & ITREL(R) SPINAL CORD STIM SYS |
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 | S036 |
Date Received | 12/20/1994 |
Decision Date | 07/13/1995 |
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 |
Approval Order Statement APPROVAL FOR RELOCATION OF THE STERILIZATION/PACKAGING FACILITY & A MODIFICATION IN THE STERILIZATION PROCESS FOR MODELS:7491,7492,7493,7494,7495,7496 & ASSOCIATED LEADS,RECEIVERS, & ACCESSORIES NEW FACILITY:COLUMBIA HEIGHTS,MINNESOTA 55421 |
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