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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceQuattrode®; Octrode™; Penta™; Lamitrode™; Tripole™; TriCentrus™ Lead Extensions
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS251
Date Received04/17/2026
Decision Date09/18/2026
Product Code LGW 
Advisory Committee Neurology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
1) optimization of the process parameter ranges of the injection molding equipment used in the manufacturing of the Bionate® 55D injection-molded portions at the stimulation and terminal ends of the Quattrode™; Octrode™; Penta™; Lamitrode™; Tripole™; and TriCentrus™ Leads and Lead Extensions at the Abbott manufacturing facility in Arecibo, Puerto Rico; and 2) qualification of a second injection molding machine of identical make, model, and configuration to the existing Nissei STX10 Machine at the Abbott manufacturing facility in Arecibo, Puerto Rico.
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