PMA P980035S844

Device: Adapta, Versa, Sensia IPG (ADDR03, ADDR06, ADSR01, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1); Adapta, Versa, S
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S844
Product code: NVZ
Decision date: 2026-07-31
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: changes to cleaning process and revising acceptance criteria for final visual inspection of hybrid subassembly

Current openFDA PMA Record#

Device: Adapta, Versa, Sensia IPG (ADDR03, ADDR06, ADSR01, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1); Adapta, Versa, S
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S844
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2026-07-31
Decision code: OK30
Date received: 2026-07-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to cleaning process and revising acceptance criteria for final visual inspection of hybrid subassembly