PMA P970042S001
- Device
- MEDSTONE STS LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P970042
- Supplement
- S001
- Product code
- NCV
- Decision date
- 2001-02-05
- Classification
- Lithotripter, Shockwave (for Treating Gallbladder Stones)
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- Approval order statement
- 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.
Current openFDA PMA Record#
- Device
- MEDSTONE STS LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P970042
- Supplement
- S001
- Product code
- NCV
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- Decision date
- 2001-02-05
- Decision code
- APPR
- Date received
- 2000-12-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- 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.