Product code MEQ
- Device name
- System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P010055S011 | ProstaLund CoreTherm System Microwave Thermotherapy for BPH | Prostalund AB | 2021-06-30 |
| P030006S028 | Prolieve Thermodilation System | Medifocus, Inc. | 2018-11-21 |
| P970008S065 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2015-10-29 |
| P970008S064 | UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH | Urologix, LLC | 2015-08-28 |
| P030006S027 | PROLIEVE THERMODILATATION SYSTEM | Medifocus, Inc. | 2014-12-16 |
| P030006S026 | PROLIEVE THERMODILATATION SYSTEM | Medifocus, Inc. | 2014-10-24 |
| P010055S009 | PROSTALUND CORETHERM SYSTEM AND PROSTALAND CORETHERM ACCESSORIES | Prostalund AB | 2014-07-30 |
| P010055S007 | PROSTALUND CORETHERM SYSTEM | Prostalund AB | 2014-01-29 |
| P000043S022 | THERMATRX OFFICE THERMOTHERAPY SYSTEM | Boston Scientific Corp | 2013-09-18 |
| P970008S063 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2013-03-05 |
| P970008S062 | TARGIS TARGETED TRANSURETHRAL THERMOABLATION SYSTEM (TARGIS SYSTEM): NEW POUCH SEALER | Urologix, LLC | 2012-12-20 |
| P030006S025 | PROLIEVE THERMODILATATION SYSTEM | Medifocus, Inc. | 2012-05-17 |
| P970008S061 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2012-03-13 |
| P970008S060 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2012-02-03 |
| P970008S058 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2011-12-09 |
| P970008S059 | TARGIS SYSTEM | Urologix, LLC | 2011-10-26 |
| P030006S024 | PROLIEVE THERMODILITATION SYSTEM | Medifocus, Inc. | 2011-05-13 |
| P970008S056 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2011-04-29 |
| P970008S055 | UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH | Urologix, LLC | 2011-03-02 |
| P970008S053 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2011-01-07 |
| P970008S052 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2010-08-27 |
| P970008S051 | UROLOGIX TARGIS SYSTEM FOT THE TREATMENT OF BPH | Urologix, LLC | 2010-07-16 |
| P970008S049 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2010-05-13 |
| P970008S048 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2010-04-30 |
| P970008S050 | UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH | Urologix, LLC | 2010-04-15 |
| P970008S047 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2010-03-31 |
| P030006S023 | PROLIEVE THERMODILITATION SYSTEM | Medifocus, Inc. | 2010-02-12 |
| P030006S022 | PROLIEVE THERMODILITATION SYSTEM | Medifocus, Inc. | 2009-11-23 |
| P970008S046 | UROLOGIX TARGIS SYSTEM | Urologix, LLC | 2009-10-22 |
| P970008S045 | UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH | Urologix, LLC | 2009-08-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07350081910013 | CoreTherm | Prostalund AB | 2016-03-07 |
| 07350081910020 | CoreTherm | Prostalund AB | 2016-03-07 |
| 07350081910037 | CoreTherm | Prostalund AB | 2016-03-07 |
| 07350081910044 | CoreTherm | Prostalund AB | 2016-03-07 |
| 07350081910051 | CoreTherm | Prostalund AB | 2016-03-07 |
| 07350081910068 | CoreTherm | Prostalund AB | 2016-03-07 |
| 07350081910075 | CoreTherm | Prostalund AB | 2016-03-07 |
| 07350081910082 | CoreTherm | Prostalund AB | 2016-03-07 |
| M876PT10340 | Targis | Urologix LLC | 2014-09-26 |
| M876PT10360 | Targis | Urologix LLC | 2014-09-26 |
| M876PT10380 | Targis | Urologix LLC | 2014-09-26 |
| M876RB3131A1 | Targis | Urologix LLC | 2014-09-26 |
| M876RB3131A2 | Targis | Urologix LLC | 2014-09-26 |