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Tendyne™ TENDV-SC

by St. Jude Medical, Inc.

Ref TENDV-SCModel Tendyne Stand Components

Tendyne™ TENDV-SC is a device classified as Class I in the EU and Class III in the US made by St. Jude Medical, Inc., registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI 5415067TMV1007SB), approved under FDA PMA P240042 on 23 May 2025 and listed in FDA GUDID since 29 May 2025 (UDI-DI 05415067032720), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA P240042

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5415067TMV1007SB Basic UDI-DI 05415067032720UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067032720 UDI-DI Date29 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP240042 Date23 May 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5415067TMV1007SB registered 15 Sep 2026 Active
  • FDA PMA P240042 decided 23 May 2025 Active
  • FDA GUDID UDI-DI 05415067032720 listed 29 May 2025 Listed

Timeline

3 dated events

  1. Approved FDA PMA P240042
  2. Listed FDA GUDID 05415067032720
  3. Registered EUDAMED 5415067TMV1007SB

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Tendyne™
Generic name
Self-expandable heart valve bioprosthesis collapsing tool, single-use
Device name
Tendyne Mitral Valves Accessories
Model / Ref / Catalog
TENDV-SC, Tendyne Stand Components
Primary DI / UDI-DI
05415067032720
Basic UDI-DI
5415067TMV1007SB
PMA number
FDA product code
NPU
EMDN code
P07038002 Cardiac valve transcatheter implant accessories
GMDN term
Self-expandable heart valve bioprosthesis collapsing tool, single-use
Device class
Class I EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class III

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Self-expandable heart valve bioprosthesis collapsing tool, single-use

Cleared under the same submission (P240042)

and 8 more cleared under P240042

Similar devices in this category

Other devices filed under CARDIAC VALVE TRANSCATHETER IMPLANT ACCESSORIES.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)