PMA P050039S004
- Device
- NOVATION CERAMIC ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S004
- Product code
- MRA
- Decision date
- 2010-12-09
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- NOVATION CERAMIC ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S004
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2010-12-09
- Decision code
- APPR
- Date received
- 2009-09-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.