|
Device | MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | MEDSTONE INTL., INC. 100 COLUMBIA, SUITE 100 ALISO VIEJO, CA 92656-4114 |
PMA Number | P870015 |
Supplement Number | S024 |
Date Received | 04/22/1996 |
Decision Date | 05/24/1996 |
Reclassified Date
|
09/08/2000 |
Product Code |
LNS |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISION OT THE "PRECAUTIONS" SECTION OF THE USER'S MANUAL |