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BIOTRONIK BIOwand

by BIOTRONIK SE & Co. KG

BIOTRONIK BIOwand (445633) is a Class III device made by BIOTRONIK SE & Co. KG, approved under FDA PMA P210037 on 31 Mar 2023 and listed in FDA GUDID since 6 Apr 2023 (UDI-DI 04035479166120), active as of 23 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 23 Oct 2026

Documents

PMA P210037

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04035479166120 UDI-DI Date6 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP210037 Date31 Mar 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P210037 decided 31 Mar 2023 Active
  • FDA GUDID UDI-DI 04035479166120 listed 6 Apr 2023 Listed

Timeline

2 dated events

  1. Approved FDA PMA P210037
  2. Listed FDA GUDID 04035479166120

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Biotronik
Generic name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system programmer
Model / Ref / Catalog
BIOwand, 445633
Primary DI / UDI-DI
04035479166120
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

Related devices

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

Cleared under the same submission (P210037)

and 8 more cleared under P210037

Similar devices

Other devices filed under FDA product code LGW (Stimulator, spinal-cord, totally implanted for pain relief).

Other devices from BIOTRONIK SE & Co. KG

See all devices from BIOTRONIK SE & Co. KG →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)