PMA P980035S722

Device: Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG,
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S722
Product code: NVZ
Decision date: 2022-07-19
Generic name: Pulse generator, permanent, implantable
Approval order statement: Reduce the frequency of the seamweld monitoring currently used to control the weld penetration at the welded interface between the left-hand and right-hand shields.

Current openFDA PMA Record#

Device: Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG,
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S722
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2022-07-19
Decision code: OK30
Date received: 2022-07-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Reduce the frequency of the seamweld monitoring currently used to control the weld penetration at the welded interface between the left-hand and right-hand shields.