DORNIER EPOS ULTRA
FDA premarket approval P000048 · decided 2002-01-15
Approval details
- PMA number
- P000048
- Trade name
- DORNIER EPOS ULTRA
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Dornier Medtech America, Inc.
- Date received
- 2000-11-21
- Decision date
- 2002-01-15
- Days to decision
- 420 days
- Decision code
- APWD
- Product code
- NBN
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR THE DORNIER EPOS ULTRA. THE DORNIER EPOS ULTRA IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC PLANTAR FASCIITIS FOR PATIENTS WITH SYMPTOMS OF PLANTAR FASCIITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPY. PLANTAR FASCIITIS IS DEFINED AS THE TRACTION DEGENERATION OF THE PLANTAR FASCIAL BAND AT ITS ORIGIN ON THE MEDICAL TUBERCLE OF THE CALCANEUS.
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 |