PMA P980035S827

Device: Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S827
Product code: NVZ
Decision date: 2025-12-03
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: to implement a rework process for seam weld defects on pacemaker pulse generators

Current openFDA PMA Record#

Device: Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S827
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2025-12-03
Decision code: OK30
Date received: 2025-11-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to implement a rework process for seam weld defects on pacemaker pulse generators