Premarket Approval (PMA)

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.

• Device: SCOLITRON(TM) STIMULATOR
• Generic Name: Stimulator, functional neuromuscular, scoliosis
• Applicant: Ebi, L.P.; 399 Jefferson Rd.; Parsippany, NJ 07054
• PMA Number: P820008
• Supplement Number: S001
• Date Received: 01/17/1983
• Decision Date: 06/14/1983
• Withdrawal Date: 09/11/2007
• Product Code: LWB
• Advisory Committee: Physical Medicine
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No