PMA P980035S734

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: S734
Product code: NVZ
Decision date: 2022-11-22
Generic name: Pulse generator, permanent, implantable
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.

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: S734
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2022-11-22
Decision code: OK30
Date received: 2022-11-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.