EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)

Basic Information

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)
• Primary DI: 00690103193176
• Version / Model: 9300TFX
• Catalog Number: 9300TFX29A
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-30
• Public Version: 5
• Public Version Date: 2022-07-04
• Public Version Status: Update
• Public Device Record Key: 3f1bfa88-71f1-47b1-be75-580715eacfdd

Device Description

EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (29MM)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
NPT	Aortic valve, prosthesis, percutaneously delivered	Unknown		3
NPV	Pulmonary Valve Prosthesis Percutaneously Delivered	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
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
60247	Pulmonary transcatheter heart valve bioprosthesis	An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is designed to be implanted with a catheter via vascular access. It may be attached to an expandable metal framework which may be expanded with a balloon or self-expand, and may include other material types (e.g., synthetic polymer). Devices associated with implantation (e.g., catheter, introducer) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103193176	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P130009	000
P130009	034
P130009	037
P130009	057

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			29 MILIMETER OUTER DIAMETER EXPANDED VALVE

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius