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 | EON MINI IPG NEUROSTIMULATION SYSTEM |
Generic Name | stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 preston road plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S028 |
Date Received | 01/08/2009 |
Decision Date | 03/19/2009 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO, LLC, IN CAGUAS, PUERTO RICO. |
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