TRANSCEND Hip Articulation System
FDA premarket approval P010001/S019 · decided 2019-03-06
Approval details
- PMA number
- P010001
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TRANSCEND Hip Articulation System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Ceramtec GmbH
- Date received
- 2019-01-28
- Decision date
- 2019-03-06
- Days to decision
- 37 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Plochingen
- Statement
- Addition of a new grinding machine for the TRANSCEND Hip Articulation System.
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