|
Device | SONOLITH 3000 LITHOTRIPTER |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | EDAP INTERNATIONAL CORP. TWO BURLINGTON WOODS BURLINGTON, MA 01803 |
PMA Number | P880011 |
Supplement Number | S009 |
Date Received | 10/29/1997 |
Decision Date | 11/06/1997 |
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 of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report). |