DORNIER COMPACT DELTA LITHOTRIPTER
FDA premarket approval P840008/S066 · decided 1998-08-21
Approval details
- PMA number
- P840008
- Supplement
- S066
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DORNIER COMPACT DELTA LITHOTRIPTER
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Dornier Medtech America, Inc.
- Date received
- 1998-07-28
- Decision date
- 1998-08-21
- Days to decision
- 24 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for modifications to the X-ray module, changes to the device labeling, and approval of the mobile and transportable versions of the Compact Delta.
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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 |