PMA P210007S010

Device: Vivistim® System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S010
Product code: QPY
Decision date: 2026-01-28
Classification: Physical Medicine
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Approval order statement: MicroTransponder has revised the following material supplier information for the Vivistim Paired VNS System (P210007): Change #1: The supplier of the Model 3000 Implantable Lead Polyester Suture has introduced a new sub-supplier of the polyester fiber subcomponent of the sutures due to discontinuation of the raw material from the original sub-supplier.Change #2: The supplier of EPO-TEK-301 has introduced a new sub-supplier of a subcomponent (Part A) of the two-part EPO-TEK-301 epoxy due to discontinuation of the raw material from the original sub-supplier.

Current openFDA PMA Record#

Device: Vivistim® System
Applicant: Mobia Medical, Inc.
PMA number: P210007
Supplement: S010
Product code: QPY
Generic name: Stimulator, autonomic nerve, implanted for stroke rehabilitation
Decision date: 2026-01-28
Decision code: OK30
Date received: 2026-01-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MicroTransponder has revised the following material supplier information for the Vivistim Paired VNS System (P210007): Change #1: The supplier of the Model 3000 Implantable Lead Polyester Suture has introduced a new sub-supplier of the polyester fiber subcomponent of the sutures due to discontinuation of the raw material from the original sub-supplier.Change #2: The supplier of EPO-TEK-301 has introduced a new sub-supplier of a subcomponent (Part A) of the two-part EPO-TEK-301 epoxy due to discontinuation of the raw material from the original sub-supplier.