PMA P090029S021
- Device
- Prestige LP (R) Cervical Disc
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P090029
- Supplement
- S021
- Product code
- MJO
- Decision date
- 2024-08-09
- Classification
- Orthopedic
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- a process change for the implementation of Blast Fixtures during the production of the PRESTIGE LP® Cervical Disc at Orchid Detroit
Current openFDA PMA Record#
- Device
- Prestige LP (R) Cervical Disc
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- PMA number
- P090029
- Supplement
- S021
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2024-08-09
- Decision code
- OK30
- Date received
- 2024-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a process change for the implementation of Blast Fixtures during the production of the PRESTIGE LP® Cervical Disc at Orchid Detroit