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 | PRECISION,PRECISION SPECTRA, PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEMS |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Boston Scientific Corp. 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P030017 |
Supplement Number | S234 |
Date Received | 08/14/2015 |
Decision Date | 11/12/2015 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MINOR DESIGN CHANGE TO THE PLUG USED IN THE DISTAL TIP OF THE 1X16 INFINION LEADS TO MAKE THE TIP PLUG OF THE 1X16 INFINION LEAD SIMILAR TO THE TIP PLUG OF THE INFINION CX LEAD. |
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