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Omnia PTRC2300

by Nevro Corporation

Omnia PTRC2300 is a Class III device made by Nevro Corporation, approved under FDA PMA P130022 on 8 May 2015 and listed in FDA GUDID since 11 Nov 2019 (UDI-DI 00813426020541), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P130022

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00813426020541 UDI-DI Date11 Nov 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP130022 Date8 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P130022 decided 8 May 2015 Active
  • FDA GUDID UDI-DI 00813426020541 listed 11 Nov 2019 Listed

Timeline

2 dated events

  1. Approved FDA PMA P130022
  2. Listed FDA GUDID 00813426020541

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Omnia
Generic name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer
Model / Ref / Catalog
PTRC2300
Primary DI / UDI-DI
00813426020541
PMA number
FDA product code
LGW
GMDN term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer

Cleared under the same submission (P130022)

and 8 more cleared under P130022

Similar devices

Other devices filed under FDA product code LGW (Stimulator, Spinal-Cord, Totally Implanted For Pain Relief).

Other devices from Nevro Corporation

See all devices from Nevro Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)