Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

FDA 510(k) clearance K183579 · decided 2019-03-29

Clearance details

K-number

K183579

Device name

Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

Applicant

Boston Scientific Neuromodulation

Decision

Substantially Equivalent

Date received

2018-12-21

Decision date

2019-03-29

Days to decision

98 days

Clearance type

Traditional

Product code

GZF

Device class

2

Regulation number

882.5870

Medical specialty

Neurology

Advisory committee

Neurology

Location

Valencia, CA, US

Third-party review

No

Expedited review

No

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