PMA P010015S485
- Device
- Consulta CRT-P, Syncra CRT-P, Viva CRT-P
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S485
- Product code
- LWP
- Decision date
- 2021-11-30
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- New handling tray and lid set for high power hybrids at Medtronics internal supplier, Medtronic Tempe Campus.
Current openFDA PMA Record#
- Device
- Consulta CRT-P, Syncra CRT-P, Viva CRT-P
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S485
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-11-30
- Decision code
- OK30
- Date received
- 2021-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New handling tray and lid set for high power hybrids at Medtronics internal supplier, Medtronic Tempe Campus.