| 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 SPINAL CORD STIMULATOR(SCS) SYSTEM AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | Boston Scientific Corp.
25155 Rye Canyon Loop
Valencia, CA 91355 |
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| PMA Number | P030017 |
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| Supplement Number | S210 |
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| Date Received | 11/24/2014 |
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| Decision Date | 02/13/2015 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE PRECISIO S8 ADAPTER THAT WILL BE USED TO CONNECT THE PRECISION IMPLANTABLE PULSE GENERATOR (IPG) OR THE PRECISION SPECTRA IPG TO THE FOLLOWING ST. JUDE MEDICAL (SJM) SCS LEADS: 3283/3286/3268/3269 LAMITRODE S8, 3280 LAMITRODE 8, 3244/3262/3263 LAMITRODE 44, 3245/3264/3265 LAMITRODE 44C, 3208 LAMITRODE TRIPOLE 8, 3210LAMITRODE TRIPOLE 8C, 3288 LAMITRODE 88, 3289 LAMITRODE 88C, 3214 LAMITRODE TRIPOLE 16C, 3219 LAMITRODE TRIPOLE 16, 3228 PENTA, 3183/3186/3189/3191 OCTRODE, 3086 OCTRODE TRIAL LEAD KIT, 2283 8-CHANNEL ADAPTER, 3341/3342/ 3343/3346 DUAL 4 EXTENSION, 3382/3383/3386SINGLE 8 EXTENSION. |
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