PMA approvals

Model 3150 IPG

Inspire Medical Systems · Stimulator, hypoglossal nerve, implanted, apnea · Anesthesiology

P130008 S147SupplementOK30
Open FDA's page for this record
PMA number
P130008
Supplement number
S147
Applicant
Inspire Medical Systems
Street 1
9700 63rd Ave. N., Suite 200
City
Maple Grove
State
MN
Zip
55369
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Trade name
Model 3150 IPG
Product code
MNQ
Advisory committee
AN
Advisory committee description
Anesthesiology
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-09-24
Decision date
2026-10-22
Decision code
OK30
Ao statement

approval for the expansion of Inspire Medical's existing Model 3028 Implantable Pulse Generator (IPG) final device manufacturer's site to produce the Model 3150 IPG

Harmonized identifiers (openFDA)
Device name
Stimulator, Hypoglossal Nerve, Implanted, Apnea
Medical specialty description
Unknown
Device class
3
Registration number
3007666314, 3009183442, 1047843, 3030384719, 2183787, 3036471728, 3008851924, 3024996452, 3030384402, 3030499299, 3010376846, 3017191859, 2183744, 3005672861, 3003857828, 2183613
FEI number
3007666314, 3009183442, 1047843, 3030384719, 2183787, 3036471728, 3008851924, 3024996452, 3030384402, 3030499299, 3010376846, 3017191859, 2183744, 3005672861, 3003857828, 2183613
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.