Stent, Urethral, Prostatic, Permanent Or Semi-Permanent
The permanent or semi-permanent prostatic urethral stent is a urology device placed endoscopically within the prostatic urethra to maintain urethral patency and relieve urinary obstruction caused by benign prostatic hyperplasia or other prostatic conditions. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MER and no regulation number or formal medical specialty has been assigned. The device is not flagged as an implant in this record and does not sustain life.
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Basic Information
- Product Code
- MER
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- GU
- Submission Type
- 2
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.