DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
FDA premarket approval P840008/S061 · decided 1997-11-03
Approval details
- PMA number
- P840008
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Dornier Medtech America, Inc.
- Date received
- 1997-10-21
- Decision date
- 1997-11-03
- Days to decision
- 13 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval to offer the Dornier X-ray Imaging Module, the Extended Image Stoarage component, and an alterantive electrocardiogram monitor as options ofor your device. In addition, the Advance Technology Laboratories ultrasound system will no longer be an option on your device. Finall, the wording of your precaution on hypertension has been modified as requested by FDA after our review of your postapproval study results.
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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 |