PMA P980035S820

Device: Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S820
Product code: NVZ
Decision date: 2025-08-12
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: process improvements to feedthrough and header hermetic testing operations

Current openFDA PMA Record#

Device: Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED
Applicant: Medtronic, Inc.
PMA number: P980035
Supplement: S820
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2025-08-12
Decision code: OK30
Date received: 2025-07-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: process improvements to feedthrough and header hermetic testing operations