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Edwards Commander Delivery System 9600LDS26

by Edwards Lifesciences LLC

Edwards Commander Delivery System 9600LDS26 (9600LDS26A) is a Class III device made by Edwards Lifesciences LLC, approved under FDA PMA P200015 on 31 Aug 2020 (1 earlier submission) and listed in FDA GUDID since 5 Jul 2015 (UDI-DI 00690103193954), active as of 22 Oct 2026. 3 FDA recalls are linked to it.

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P200015

+1 more

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR from GUDID Approved NumberP200015 Date31 Aug 2020DecidedStatusActive
United StatesGUDID listing Number00690103193954 UDI-DI Date5 Jul 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA PMA P200015 decided 31 Aug 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00690103193954 listed 5 Jul 2015 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0835-2019 FDA Class II initiated 22 Jan 2019

    This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

    • Terminated Z-2435-2018 FDA Class II initiated 11 Jun 2018

    SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.

    • Terminated Z-0293-2018 FDA Class I initiated 21 Jul 2017

    A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.

Timeline

6 dated events

  1. Approved FDA PMA P140031
  2. Listed FDA GUDID 00690103193954
  3. Recall initiated FDA recalls Z-0293-2018
  4. Recall initiated FDA recalls Z-2435-2018
  5. Recall initiated FDA recalls Z-0835-2019
  6. Approved FDA PMA P200015

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Edwards Commander Delivery System
Generic name
Pulmonary transcatheter heart valve bioprosthesis
Model / Ref / Catalog
9600LDS26, 9600LDS26A
Primary DI / UDI-DI
00690103193954
PMA number
FDA product code
NPU, NPT, NPV
GMDN term
Pulmonary transcatheter heart valve bioprosthesis
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Aortic transcatheter heart valve bioprosthesis, stent-like frameworkMitral transcatheter heart valve bioprosthesisPulmonary transcatheter heart valve bioprosthesis

Cleared under the same submission (P140031)

and 8 more cleared under P140031

Cleared under the same submission (P200015)

and 3 more cleared under P200015

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)