# P030006: Prolieve Thermodilatation  System

- Pathway: PMA
- Applicant: Medifocus, Inc.
- Decided: Feb 19, 2004 after 332 days
- Product code: MEQ (System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy)
- Device class: 3
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Jul 20, 2009 · Not classified · Z-1692-2009: Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led
- May 4, 2006 · Not classified · Z-1248-06: A medical device accessory used by healthcare practitioners in the invasive treatment of (BPH) benign prostatic hyperplasia may be defective. The catheter may fail to achieve or maintain recommended p
- Mar 22, 2006 · Not classified · Z-0843-06: Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.
- Jul 19, 2004 · Not classified · Z-1339-04: Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.

Source page: https://510kreport.com/device/P030006
Methodology: https://510kreport.com/methodology