PMA P050039S009
- Device
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S009
- Product code
- MRA
- Decision date
- 2012-04-26
- 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 CHANGES TO THE NOVATION® AHS INSTRUCTIONS FOR USE TO REORGANIZE INFORMATION FOR CLARITY, REMOVE INFORMATION THAT IS REDUNDANT, AND ENSURE CONSISTENCY.
Current openFDA PMA Record#
- Device
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S009
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2012-04-26
- Decision code
- APPR
- Date received
- 2012-03-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE NOVATION® AHS INSTRUCTIONS FOR USE TO REORGANIZE INFORMATION FOR CLARITY, REMOVE INFORMATION THAT IS REDUNDANT, AND ENSURE CONSISTENCY.