FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Ablation Catheter, Renal Denervation
PMA: P220026
·
Supplement: S003
·
Decision Feb 28, 2024
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Ablation Catheter, Renal Denervation
- Trade Name
- Symplicity Spyral Multi Electrode Renal Denervation Catheter
- PMA Number
- P220026
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- QYI
- Generic Name
- Ablation catheter, renal denervation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- February 28, 2024
- Date Received
- January 29, 2024
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
the addition of an electron beam sterilization line at the existing contract sterilizer location
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 |
|---|---|---|---|
| QYI | Ablation Catheter, Renal Denervation | FDA class 3 | Unknown |