DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
FDA premarket approval P970044/S001 · decided 1998-06-23
Approval details
- PMA number
- P970044
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Dornier Medtech America, Inc.
- Date received
- 1998-06-15
- Decision date
- 1998-06-23
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for the removal of the External INterstitial Thermometry System from the Urowave(R).
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 |
|---|---|---|
| Delta III Pro (K221903) | Dornier Medtech America, Inc. | 2023-02-22 |
| Dornier Thulio (K213252) | Dornier Medtech America, Inc. | 2022-07-27 |
| Nautilus (K220871) | Dornier Medtech America, Inc. | 2022-04-18 |
| Electrosurgical accessory (K210394) | Dornier Medtech America, Inc. | 2021-05-19 |
| Dornier MAGELLAN Ureteral Access Sheath (K201815) | Dornier Medtech America, Inc. | 2020-11-20 |
| Delta III Lithotripter (K201074) | Dornier Medtech America, Inc. | 2020-09-03 |
| EQUINOX Balloon Dilatation Catheter (K190612) | Dornier Medtech America, Inc. | 2019-12-06 |
| Dornier Ureteral Stent (K190312) | Dornier Medtech America, Inc. | 2019-11-15 |