EnVeo™ PRO
GUDID 00643169987203
18FR DELIV SYS ENVPRO-14-US
MEDTRONIC, INC.
Aortic transcatheter heart valve bioprosthesis, stent-like framework| Primary Device ID | 00643169987203 |
| NIH Device Record Key | 9fbb9ea6-489d-4529-8bdf-8338b353c8ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnVeo™ PRO |
| Version Model Number | ENVPRO-14-US |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 107 Centimeter |
| Length | 107 Centimeter |
| Length | 107 Centimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
| Outer Diameter | 6 Millimeter |
| Length | 107 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the catheter and LS in a cool, dry environment. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169987203 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P130021
FDA Product Code
| NPT | Aortic valve, prosthesis, percutaneously delivered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-28 |
On-Brand Devices [EnVeo™ PRO]
| 00643169987210 | 20FR DELIV SYS ENVPRO-16-US |
| 00643169987203 | 18FR DELIV SYS ENVPRO-14-US |
| 00643169987197 | LOAD SYS L-ENVPRO-1623-US |
| 00643169987180 | LOAD SYS L-ENVPRO-16-US |
| 00643169987173 | LOAD SYS L-ENVPRO-14-US |
Trademark Results [EnVeo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENVEO 85813931 5041360 Live/Registered |
Medtronic CV Luxembourg S.a.r.l. 2013-01-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.