PMA P050039S005
- Device
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S005
- Product code
- MRA
- Decision date
- 2011-03-31
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/ceramic/ceramic/metal, Cemented Or Uncemented
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Approval order statement
- APPROVAL FOR LABELING CHANGES WHICH ADD STRENGTHENING LANGUAGE TO THE FEMORAL STEM SURGICAL TECHNIQUE MANUALS.
Current openFDA PMA Record#
- Device
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S005
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2011-03-31
- Decision code
- APPR
- Date received
- 2011-03-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES WHICH ADD STRENGTHENING LANGUAGE TO THE FEMORAL STEM SURGICAL TECHNIQUE MANUALS.