Product code NXW
- Device name
- Scaffold, Infrapopliteal, Absorbable
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The absorbable scaffold is for improving luminal diameter for the treatment of lesions in native infrapopliteal arteries.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P230036S018 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2026-05-22 |
| P230036S016 | Esprit BTK RX System; Esprit BTK OTW System | ABBOTT MEDICAL | 2025-10-22 |
| P230036S015 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2025-09-26 |
| P230036S014 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2025-08-29 |
| P230036S013 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2025-08-08 |
| P230036S012 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2025-07-25 |
| P230036S011 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2025-06-27 |
| P230036S010 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2025-04-16 |
| P230036S008 | ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System | ABBOTT MEDICAL | 2024-12-18 |
| P230036S007 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2024-12-11 |
| P230036S009 | Esprit BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2024-12-10 |
| P230036S006 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2024-08-28 |
| P230036S004 | ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System | ABBOTT MEDICAL | 2024-08-23 |
| P230036S005 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2024-07-26 |
| P230036S003 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2024-06-21 |
| P230036S002 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2024-05-30 |
| P230036S001 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2024-05-29 |
| P230036 | Esprit™ BTK Everolimus Eluting Resorbable Scaffold System | ABBOTT MEDICAL | 2024-04-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08717648353765 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-12 |
| 08717648353666 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648353680 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648353703 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648353741 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648353789 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648353826 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648353840 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648353864 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648353987 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648354007 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648354021 | Esprit™ | ABBOTT VASCULAR INC. | 2025-07-10 |
| 08717648357152 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-09 |
| 08717648356971 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648356995 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648357015 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648357053 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648357077 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648357091 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648357138 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648357176 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648357213 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648357237 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |
| 08717648357251 | Esprit™ | ABBOTT VASCULAR INC. | 2024-05-07 |