FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Scaffold, Infrapopliteal, Absorbable
PMA: P230036
·
Supplement: S003
·
Decision Jun 21, 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
- S003
- Device Class
- FDA Class 3
- Product Code
- NXW
- Generic Name
- Scaffold, infrapopliteal, absorbable
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 21, 2024
- Date Received
- May 24, 2024
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the protocol for the new enrollment post-approval study (PAS)
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 |