FDA UDI
In Commercial Distribution
🇺🇸 United States
Evolut™ FX+
DI: 00763000716127
·
Model: EVFXPLUS-23
·
MEDTRONIC COREVALVE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Evolut™ FX+
- Primary DI
- 00763000716127
- Version / Model
- EVFXPLUS-23
- Company Name
- MEDTRONIC COREVALVE LLC
- Labeler DUNS
- 079527231
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-03
- Public Version
- 1
- Public Version Date
- 2024-05-13
- Public Version Status
- New
- Public Device Record Key
- 2289329a-4929-4774-83ab-fc9caa98637c
Device Description
TAV EVFXPLUS-23 COMM US
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
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000716127 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130021 | 155 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 23 MM |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the bioprosthesis at room temperature. Avoid exposing to extreme fluctuations of temperature. Avoid freezing.