Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

Basic Information

Brand Name: Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Primary DI: 00690103201321
Version / Model: 9750TFX23
Catalog Number: 9750TFX23A
Company Name: Edwards Lifesciences LLC
Labeler DUNS: 134139174
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2019-01-08
Public Version: 9
Public Version Date: 2022-08-26
Public Version Status: Update
Public Device Record Key: 27fd6964-778d-4211-be64-e6308c75a299

Device Description

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Conditional
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NPU	Prosthesis, Mitral Valve, Percutaneously Delivered	Unknown		3
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active
60246	Mitral transcatheter heart valve bioprosthesis	An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant mitral heart valve, or previously-implanted mitral heart valve prosthesis, and which is implanted with a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices to assist implantation (e.g., catheter, introducer) are typically included.	Yes	Active
60245	Aortic transcatheter heart valve bioprosthesis, stent-like framework	An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to an expandable metal framework, which is implanted with an included catheter, and when in situ, may be expanded with a balloon or self-expand. Typically devices associated with implantation (e.g., catheter, introducer) are included.	Yes	Active
16463	Basic crimper	A hand-held manual device designed to compress (pinch) a non-patient-contact sealing device (e.g., a clip or crimping ring of metal applied apart from the body) to reduce its size (diameter) and create a tight seal on objects being clamped or held together. This is performed by the application of force on the grip of the crimper's handles by the operator. This is a reusable device.	No	Active
17541	Catheter/overtube balloon inflator, single-use	A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103201321	GS1

Customer Contacts

Phone: +1(800)822-9637
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P140031	074
P140031	085
P140031	088
P140031	099
P140031	107
P140031	112
P140031	114
P140031	125

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Outer Diameter, 23 MM

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Do Not Freeze. Store between 10 and 25 Celsius degree.