- Device
- DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S067
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1999-03-12
- Decision code
- APRL
- Date received
- 1999-02-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Dornier Medizintechnik GmbH, Argeisrieder Feld 7, D-82234 Wessling, Germany.