| 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) Systems |
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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 | S377 |
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| Date Received | 07/29/2024 |
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| Decision Date | 01/21/2026 |
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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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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the following changes related to the OR cables and extensions: 1) an alternate manufacturing site (i.e., Jiangyin SINBON Electronics Co. Ltd., FDA Establishment Identifier – 3007616088), 2) dimensional changes, 3) change of material for two polyurethane components (i.e., strain relief and cable jacket) to a trademarked thermoplastic polyurethane (i.e., IROGRAN A75E 5040), and 4) removal of a duplicative cleaning step. |
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