PMA P220002S001
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- PMA number
- P220002
- Supplement
- S001
- Product code
- QWK
- Decision date
- 2023-08-11
- Classification
- Orthopedic
- Generic name
- Prosthesis, posterior spinal elements
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- TOPS™ System
- Applicant
- Premia Spine, Ltd.
- PMA number
- P220002
- Supplement
- S001
- Product code
- QWK
- Generic name
- Prosthesis, posterior spinal elements
- Decision date
- 2023-08-11
- Decision code
- APPR
- Date received
- 2023-07-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.