PMA P980035S826
- Device
- Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S826
- Product code
- NVZ
- Decision date
- 2025-12-03
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- an update to the substrate defect mapping process
Current openFDA PMA Record#
- Device
- Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S826
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2025-12-03
- Decision code
- OK30
- Date received
- 2025-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the substrate defect mapping process