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Tendyne™ TENDV-SP-41S

by St. Jude Medical, Inc.

Tendyne™ TENDV-SP-41S is a Class III device made by St. Jude Medical, Inc., approved under FDA PMA P240042 on 23 May 2025 and listed in FDA GUDID since 29 May 2025 (UDI-DI 05415067032553), 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 P240042

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 Number05415067032553 UDI-DI Date29 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP240042 Date23 May 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P240042 decided 23 May 2025 Active
  • FDA GUDID UDI-DI 05415067032553 listed 29 May 2025 Listed

Timeline

2 dated events

  1. Approved FDA PMA P240042
  2. Listed FDA GUDID 05415067032553

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Tendyne™
Generic name
Mitral transcatheter heart valve bioprosthesis
Model / Ref / Catalog
TENDV-SP-41S
Primary DI / UDI-DI
05415067032553
PMA number
FDA product code
NPU
GMDN term
Mitral transcatheter heart valve bioprosthesis
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Mitral transcatheter heart valve bioprosthesis

Cleared under the same submission (P240042)

and 8 more cleared under P240042

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Serial number
  • Expiration date
Other properties (9, all answered No)