S-ROM POLY-DAIL CONSTRAINED LINER
FDA premarket approval P960054/S003 · decided 1999-12-22
Approval details
- PMA number
- P960054
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- S-ROM POLY-DAIL CONSTRAINED LINER
- Generic name
- Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
- Applicant
- Depuy, A Johnson & Johnson Co.
- Date received
- 1999-08-10
- Decision date
- 1999-12-22
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- KWZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- Approva for the cleaning and packaging site located at DePuy (Ireland) Ltd., Loughbeg, Ringaskiddy, Cork. Ireland and the sterilization facility located at ISOTRON plc, Marcus Close, Tilehurst, Reading, Berkshire FG30 4EA, England.
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