- Device
- EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM
- Applicant
- Exactech, Inc.
- PMA number
- P050039
- Supplement
- S010
- Product code
- MRA
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Decision date
- 2012-08-24
- Decision code
- OK30
- Date received
- 2012-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE PROCESS FOR USE OF THE BURST TEST FIXTURE, WHICH IS USED TO EVALUATE THE SEAL STRENGTH OF THE PACKAGING.