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.
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.
| Device | MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES |
| Classification Name | Lithotripter, Shockwave (for Treating Gallbladder Stones) |
| Generic Name | Lithotripter, Shockwave (for Treating Gallbladder Stones) |
| Applicant | MEDSTONE INTL., INC. |
| Date Received | 2002-08-02 |
| Decision Date | 2003-01-28 |
| PMA | P970042 |
| Supplement | S004 |
| Product Code | NCV |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDSTONE INTL., INC. 100 Columbia, Suite 100 aliso Viejo, CA 92656-4114 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970042 | Original Filing | |
| S004 | 2002-08-02 | Normal 180 Day Track |
| S003 | 2002-07-03 | Normal 180 Day Track |
| S002 | 2002-02-21 | Normal 180 Day Track |
| S001 | 2000-12-18 | Normal 180 Day Track |