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 several changes to the post-approval study protocol. Specifically, these changes are 1) changes to inclusion criteria 3 and 5 2) changes to exclusion criteria 7, 8, 9, 10, 11, 13, 15, and 16 3) elimination of the ultrasound evaluation immediately post-lithotripsy, 4) elimination of the oral cholecystogram at the six-month visit, and 5) addition of statements to clarify guidelines for scheduling follow-up visits and to list protocol requirements by study visit.
| Device | MEDSTONE STS LITHOTRIPTER |
| Classification Name | Lithotripter, Shockwave (for Treating Gallbladder Stones) |
| Generic Name | Lithotripter, Shockwave (for Treating Gallbladder Stones) |
| Applicant | MEDSTONE INTL., INC. |
| Date Received | 2000-12-18 |
| Decision Date | 2001-02-05 |
| PMA | P970042 |
| Supplement | S001 |
| 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 |