PMA P870015S024
- Device
- MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S024
- Product code
- LNS
- Decision date
- 1996-05-24
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- APPROVAL FOR REVISION OT THE "PRECAUTIONS" SECTION OF THE USER'S MANUAL
Current openFDA PMA Record#
- Device
- MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S024
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1996-05-24
- Decision code
- APRL
- Date received
- 1996-04-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISION OT THE "PRECAUTIONS" SECTION OF THE USER'S MANUAL