| Note: 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. |
| |
| Device | InterStim Therapy System, Verify Evaluation System (SNS Urinary) |
|---|
| Generic Name | Stimulator, electrical, implantable, for incontinence |
|---|
| Regulation Number | 876.5270 |
|---|
| Applicant | Medtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432 |
|---|
| PMA Number | P970004 |
|---|
| Supplement Number | S321 |
|---|
| Date Received | 11/03/2020 |
|---|
| Decision Date | 11/30/2020 |
|---|
| Product Code |
EZW |
| Advisory Committee |
Gastroenterology |
|---|
| Supplement Type | 30-Day Notice |
|---|
| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
| Recalls | CDRH Recalls |
|---|
Approval Order Statement
Addition of Meier Tool & Engineering (Meier Tool), Anoka, MN - USA as an alternate supplier for a battery component (second source) for the uncoated battery cathode current collector that is consumed into titanium coated cathode current collectors and eventually into the Delta 26H2 and Delta 26H3 medium rate batteries further used in implantable neurostimulators. And the addition of Incoming Inspection Procedures for Uncoated and Coated Cathode Current Collector Components Originating from Meier Tool. |
|
|
