TRILOGY AB ACETABULAR SYSTEM PACKAGE INSERT
FDA premarket approval P040048/S014 · decided 2011-06-02
Approval details
- PMA number
- P040048
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TRILOGY AB ACETABULAR SYSTEM PACKAGE INSERT
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Zimmer, Inc.
- Date received
- 2011-05-02
- Decision date
- 2011-06-02
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR ADDING INFORMATION ABOUT MRI SAFETY TO THE PACKAGE INSERT AND PATIENT LABELING.
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