PMA P970042S004
- Device
- MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES
- Applicant
- Medstone Intl., Inc.
- PMA number
- P970042
- Supplement
- S004
- Product code
- NCV
- Decision date
- 2003-01-28
- Classification
- Lithotripter, Shockwave (for Treating Gallbladder Stones)
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- 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.
Current openFDA PMA Record#
- Device
- MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES
- Applicant
- Medstone Intl., Inc.
- PMA number
- P970042
- Supplement
- S004
- Product code
- NCV
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- Decision date
- 2003-01-28
- Decision code
- APPR
- Date received
- 2002-08-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- 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.