Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | S-ROM POLY-DAIL CONSTRAINED LINER |
Generic Name | Prosthesis, hip, constrained, cemented or uncemented, metal/polymer |
Regulation Number | 888.3310 |
Applicant | DEPUY, A JOHNSON & JOHNSON CO. P.O. BOX 988 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P960054 |
Supplement Number | S003 |
Date Received | 08/10/1999 |
Decision Date | 12/22/1999 |
Reclassified Date
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05/30/2002 |
Product Code |
KWZ |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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