PMA P160036S001
- Device
- Hintermann Series H3 Total Ankle Replacement System
- Applicant
- Dt Medtech, LLC
- PMA number
- P160036
- Supplement
- S001
- Product code
- NTG
- Decision date
- 2019-11-29
- Classification
- Prosthesis, Ankle, Uncemented, Non-constrained
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Approval order statement
- Approval for the post-approval study protocols for the two post-approval studies.
Current openFDA PMA Record#
- Device
- Hintermann Series H3 Total Ankle Replacement System
- Applicant
- Dt Medtech, LLC
- PMA number
- P160036
- Supplement
- S001
- Product code
- NTG
- Generic name
- Prosthesis, ankle, uncemented, non-constrained
- Decision date
- 2019-11-29
- Decision code
- APPR
- Date received
- 2019-07-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the post-approval study protocols for the two post-approval studies.