UROLOGIX PROSTATRON SYSTEM
FDA premarket approval P950014/S026 · decided 2008-07-16
Approval details
- PMA number
- P950014
- Supplement
- S026
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLOGIX PROSTATRON SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 2008-03-14
- Decision date
- 2008-07-16
- Days to decision
- 124 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR DESIGN MODIFICATIONS WHICH INCLUDE A NEW CATHETER TIP MATERIAL, RED MARK ADHESIVE, BONDING ADHESIVES, INJECTION MOLD FOR MANUFACTURING THE CATHETER TIP, AND A NEW STERILE BALLOON INFLATION STOPCOCK. THE PRODUCTION OF THE PROSTAPROBE TYPE II, SILICONE, BLUE TREATMENT CATHETER (PART NUMBER 410053-004) WILL BE MANUFACTURED AT MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.