DORNIER COMPACT DELTA
FDA premarket approval P840008/S065 · decided 1998-07-07
Approval details
- PMA number
- P840008
- Supplement
- S065
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DORNIER COMPACT DELTA
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Dornier Medtech America, Inc.
- Date received
- 1998-06-25
- Decision date
- 1998-07-07
- Days to decision
- 12 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for changes tot he therapy head movement capabilities, alteration of the hand held control unit, modification of the X-ray range of movement, addition of an X-ray image storage feature, ECG monitor model replacement, replacement of the charging unit, a new mounting orientation for the ultrasound arm, design changes to the patient table, a new design for the phantom support accessory, software modifications, and labeling changes. The device, as modified, will be marketed under the trade
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|---|---|---|
| Delta III Pro (K221903) | Dornier Medtech America, Inc. | 2023-02-22 |
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| 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 |