PMA P050039S001
- Device
- NOVATION CERAMIC AHS
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S001
- Product code
- MRA
- Decision date
- 2008-11-13
- 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 AN ADDITIONAL MACHINING PROCESSES AT EXACTECH, INC. IN GAINESVILLE, FLORIDA.
Current openFDA PMA Record#
- Device
- NOVATION CERAMIC AHS
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S001
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2008-11-13
- Decision code
- APPR
- Date received
- 2007-10-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL MACHINING PROCESSES AT EXACTECH, INC. IN GAINESVILLE, FLORIDA.