DEVICE: Precision Spectra ™ (08714729821526)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Precision Spectra ™
SC-1132
In Commercial Distribution

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
08714729821526
GS1

1
824951958 *Terms of Use
Implantable Pulse Generator Kit
CLOSE

Device Characteristics
MR Conditional
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
CLOSE

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
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P030017 134
P030017 168
P030017 181
P030017 198
P030017 206
P030017 208
P030017 245
P030017 259
P030017 270
P030017 273
P030017 278
P030017 306
P030017 328
P030017 357
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
079b48ca-e27e-4832-b5c2-23887e4032ef
August 20, 2024
4
December 14, 2015
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE