DEVICE: Precision™ (08714729767688)

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Device Identifier (DI) Information
Precision™
SC-1110-02
In Commercial Distribution

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
08714729767688
GS1

1
824951958 *Terms of Use
Implantable Pulse Generator Kit
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
64970 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
QRB Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P030017 002
P030017 012
P030017 057
P030017 071
P030017 082
P030017 084
P030017 098
P030017 130
P030017 140
P030017 144
P030017 229
P030017 270
P030017 278
P030017 357
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Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
7b189a8f-290c-4b40-a11f-a64efef01d8d
March 13, 2024
4
December 14, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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