PMA P980035S835
- Device
- CareLink SmartSync™ Adapta™ Versa™ Sensia™ Application (D00U014)
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S835
- Product code
- NVZ
- Decision date
- 2026-05-06
- Classification
- Cardiovascular
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- approval for new CareLink SmartSync Adapta Versa Sensia application and supporting software and firmware platform updates
Current openFDA PMA Record#
- Device
- CareLink SmartSync™ Adapta™ Versa™ Sensia™ Application (D00U014)
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S835
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2026-05-06
- Decision code
- APPR
- Date received
- 2026-02-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for new CareLink SmartSync Adapta Versa Sensia application and supporting software and firmware platform updates