Optilume BPH Catheter System
FDA premarket approval P220029/S002 · decided 2024-08-15
Approval details
- PMA number
- P220029
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Optilume BPH Catheter System
- Generic name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia
- Applicant
- Urotronic, Inc.
- Date received
- 2024-05-21
- Decision date
- 2024-08-15
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- QXB
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval for a change in supplier for two kit components (i.e., the Tuohy-Borst adapter and stopcock), a change in kit packaging of the components (i.e., addition of the Tuohy-Borst adapter and Stopcock to the Pre-Dilation Catheter Tyvek Pouch), and a change in labeling to remove the vascular meta-analysis information from the Instructions for Use
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Optilume® High Pressure Urological Balloon Dilation Catheter (K250910) | Urotronic, Inc. | 2025-05-22 |
| Optilume Basic Urological Balloon Dilation Catheter (K191061) | Urotronic, Inc. | 2020-01-02 |