DORNIER COMPACT S
FDA premarket approval P840008/S056 · decided 1996-11-05
Approval details
- PMA number
- P840008
- Supplement
- S056
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DORNIER COMPACT S
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Dornier Medtech America, Inc.
- Date received
- 1996-07-01
- Decision date
- 1996-11-05
- Days to decision
- 127 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- DESIGN MODIFICATIONS:1)THE USE OF THE PERFORMA ULTRASOUND IMAGING SYSTEM 2)ADDITION OF X-RAY IMAGING AND 3)MINOR DESIGN CHANGES. THE DEVICE AS MODIFIED WILL E MARKETD UNDER THE TRADE NAME DORNIER COMPACT S LITHOTRIPTER AND IS INDICATED FOR THE FRAGMENTATION OF 5 TO 25 MILLIMETER KIDNEY STONES SUCH AS RENAL CALYX STONES AND RENAL PELVIC STONES
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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 |