PMA P010015S513
- Device
- Consulta CRT-P, Syncra CRT-P
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S513
- Product code
- LWP
- Decision date
- 2023-02-03
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Implement manufacturing process updates at a capacitor supplier.
Current openFDA PMA Record#
- Device
- Consulta CRT-P, Syncra CRT-P
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S513
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2023-02-03
- Decision code
- OK30
- Date received
- 2023-01-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement manufacturing process updates at a capacitor supplier.