PMA P220026S003
- Device
- Symplicity Spyral Multi Electrode Renal Denervation Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P220026
- Supplement
- S003
- Product code
- QYI
- Decision date
- 2024-02-28
- Classification
- Cardiovascular
- Generic name
- Ablation catheter, renal denervation
- Approval order statement
- the addition of an electron beam sterilization line at the existing contract sterilizer location
Current openFDA PMA Record#
- Device
- Symplicity Spyral Multi Electrode Renal Denervation Catheter
- Applicant
- Medtronic, Inc.
- PMA number
- P220026
- Supplement
- S003
- Product code
- QYI
- Generic name
- Ablation catheter, renal denervation
- Decision date
- 2024-02-28
- Decision code
- OK30
- Date received
- 2024-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of an electron beam sterilization line at the existing contract sterilizer location