PMA P010015S580
- Device
- Consulta CRT-P C4TR01 Syncra CRT-P C2TR01
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S580
- Product code
- LWP
- Decision date
- 2026-02-12
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- manufacturing and test process improvements for integrated circuits
Current openFDA PMA Record#
- Device
- Consulta CRT-P C4TR01 Syncra CRT-P C2TR01
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S580
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-02-12
- Decision code
- OK30
- Date received
- 2026-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing and test process improvements for integrated circuits