Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | Paradise™ Ultrasound Renal Denervation System (Paradise System), Paradise™ Cartridge |
Generic Name | Ablation catheter, renal denervation |
Applicant | ReCor Medical, Inc. 1049 Elwell Court Palo Alto, CA 94303 |
PMA Number | P220023 |
Supplement Number | S001 |
Date Received | 11/20/2023 |
Decision Date | 12/06/2023 |
Product Code |
QYI |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement modification of the cartridge packaging tray |
|
|