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 | PINNACLE COMPLETE ACETABULAR HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, ceramic-on-metal articulation |
Applicant | DEPUY ORTHOPAEDICS, INC. P.O BOX 988 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 |
PMA Number | P090002 |
Supplement Number | S006 |
Date Received | 10/25/2012 |
Decision Date | 11/20/2012 |
Withdrawal Date
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09/05/2013 |
Product Code |
OVO |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES TO THE SEALING PARAMETERS FOR TWO POUCH SEALERS USED FOR SROM SLEEVES BLISTER PACKS. |
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