MEDTRONIC INTERSTIM TINED LEAD
FDA premarket approval P970004/S030 · decided 2004-11-24
Approval details
- PMA number
- P970004
- Supplement
- S030
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MEDTRONIC INTERSTIM TINED LEAD
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2004-08-30
- Decision date
- 2004-11-24
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MODIFICATION OF THE INFORMED CONSENT DOCUMENT, CASE REPORT FORMS, THE INVESTIGATOR AGREEMENT, AND THE VOIDING DIARY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |