Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES |
Generic Name | Lithotripter, shockwave (for treating gallbladder stones) |
Applicant | MEDSTONE INTL., INC. 100 COLUMBIA, SUITE 100 ALISO VIEJO, CA 92656-4114 |
PMA Number | P970042 |
Supplement Number | S004 |
Date Received | 08/02/2002 |
Decision Date | 01/28/2003 |
Withdrawal Date
|
02/10/2004 |
Product Codes |
LNS NCV |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR 1) A CHANGE IN THE INCLUSION AGE LIMIT FOR THE POST-APPROVAL STUDY FROM 18-70 TO 18 AND OVER; 2) A CHANGE IN THE POST APPROVAL STUDY'S MONITORING FROM RSI TO MEDSTONE; AND 3) A CHANGE IN THE POST-APPROVAL STUDY'S MEDICAL MONITOR FROM RSI TO MICHAEL ALBERT, M.D. |
|
|