PMA P220002S008
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- PMA number
- P220002
- Supplement
- S008
- Product code
- QWK
- Decision date
- 2025-05-29
- Classification
- Orthopedic
- Generic name
- Prosthesis, posterior spinal elements
- Approval order statement
- qualification of an additional VST leakage testing machine for the TOPS™ System implant at the Ramat Poleg, Netanya, Israel facility
Current openFDA PMA Record#
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- PMA number
- P220002
- Supplement
- S008
- Product code
- QWK
- Generic name
- Prosthesis, posterior spinal elements
- Decision date
- 2025-05-29
- Decision code
- OK30
- Date received
- 2025-05-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of an additional VST leakage testing machine for the TOPS™ System implant at the Ramat Poleg, Netanya, Israel facility