FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Scaffold, Infrapopliteal, Absorbable
PMA: P230036
·
Supplement: S005
·
Decision Jul 26, 2024
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Scaffold, Infrapopliteal, Absorbable
- Trade Name
- Esprit BTK Everolimus Eluting Resorbable Scaffold System
- PMA Number
- P230036
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- NXW
- Generic Name
- Scaffold, infrapopliteal, absorbable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- July 26, 2024
- Date Received
- June 28, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
an alternative scaffold/balloon crimp process
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NXW | Scaffold, Infrapopliteal, Absorbable | FDA class 3 | Unknown |