FDA Product Code PPN: Percutaneous Catheter, Ultrasound
Intended For Ultrasound Wave Enhanced Balloon Dilatation Of Lesions, Including Calcified Lesions, In The Peripheral Vasculature.
Leading manufacturers include Shockwave Medical, Inc. and Bolt Medical, Inc..
FDA 510(k) Cleared Percutaneous Catheter, Ultrasound Devices (Product Code PPN)
About Product Code PPN - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code PPN since 2016, with 12 receiving FDA clearance (average review time: 70 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under PPN have taken an average of 59 days to reach a decision - down from 72 days historically, suggesting improved FDA processing for this classification.
PPN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →