| 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. |
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| Device | InterStim Therapy System, Verify Evaluation System |
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| Generic Name | Stimulator, electrical, implantable, for incontinence |
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| Regulation Number | 876.5270 |
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| Applicant | Medtronic Neuromodulation
7000 Central Ave., NE
Minneapolis, MN 55432 |
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| PMA Number | P970004 |
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| Supplement Number | S338 |
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| Date Received | 08/03/2021 |
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| Decision Date | 09/01/2021 |
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| Product Code |
EZW |
| Advisory Committee |
Gastroenterology |
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| Supplement Type | 30-Day Notice |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
Wquipment updates in the CEA 2-3 Silicone Molding area (e.g., six additional ovens), updated option for use of temperature recorder (Vaisala Monitoring System Model VL-1700-54T), updated oven mode for the new ovens to use Manual Mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (Nikon MM-40); 2) an update to the applicable work instructions (WI); and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and FACTORYworks (FW) updates to support the changes. |
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