Axium™ MN10100

by St. Jude Medical, Inc.

Axium™ MN10100 is a Class III device made by St. Jude Medical, Inc., approved under FDA PMA P150004 on 11 Feb 2016 and listed in FDA GUDID since 29 Mar 2016 (UDI-DI 05415067025494), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05415067025494 UDI-DI	Date29 Mar 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA PMAAPPR from GUDID Approved	NumberP150004	Date11 Feb 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05415067025494
FDA PMA database PMA number P150004

Across registries

2 registries list this device

FDA PMA P150004 decided 11 Feb 2016 Active
FDA GUDID UDI-DI 05415067025494 listed 29 Mar 2016 Listed

Timeline

2 dated events

11 Feb 2016 Approved FDA PMA P150004
29 Mar 2016 Listed FDA GUDID 05415067025494

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name: Axium™
Generic name: Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
Model / Ref / Catalog: MN10100

Primary DI / UDI-DI: 05415067025494
PMA number: P150004
FDA product code: PMP
GMDN term: Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

Device class: Class III
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)