FDA.reportPublic FDA data

PMA P980035S845

Device
Adapta, Versa, Sensia IPG (ADDR06, ADDRS1, ADSR01, ADSR03, ADSR06, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1);
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S845
Product code
NVZ
Decision date
2026-07-31
Classification
Cardiovascular
Generic name
Pulse generator, permanent, implantable
Approval order statement
to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.

Current openFDA PMA Record#

Device
Adapta, Versa, Sensia IPG (ADDR06, ADDRS1, ADSR01, ADSR03, ADSR06, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1);
Applicant
Medtronic, Inc.
PMA number
P980035
Supplement
S845
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
to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.