|
Device | InterStim Therapy System and Verify Evaluation System |
Generic Name | Implanted electrical device intended for treatment of fecal incontinence |
Regulation Number | 876.5270 |
Applicant | MEDTRONIC NEUROMODULATION 7000 CENTRAL AVENUE NE MS RCW225 MINNEAPOLIS, MN 55432 |
PMA Number | P080025 |
Supplement Number | S221 |
Date Received | 11/19/2020 |
Decision Date | 12/16/2020 |
Product Code |
QON |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement the proposed transfer of manufacturing activities of the lead assembly to the Heraeus Costa Rica manufacturing facility and minor manufacturing equipment changes at the facility to support the proposed transfer. Also, changes to a processing aid used during the manufacturing process of the material that is used at Heraeus Medical Components to coat the lead assembly. |