Commander 9750CM29

by Edwards Lifesciences LLC

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

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

3 closed

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00690103217001 UDI-DI	Date25 Aug 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA PMAAPPR from GUDID Approved	NumberP140031	Date17 Jun 2015Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00690103217001
FDA PMA database PMA number P140031

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.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name: Commander
Generic name: Catheter/overtube balloon inflator, single-use
Model / Ref / Catalog: 9750CM29, 9750CM29A

Primary DI / UDI-DI: 00690103217001
PMA number: P140031
FDA product code: NPU, NPT
GMDN term: Catheter/overtube balloon inflator, single-use

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

MRI safety: MR Conditional

Size: Outer Diameter — 29 Millimeter

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See all devices from Edwards Lifesciences LLC →

Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10)

Sterilise before use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Manufacturing date: No