Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: ITRELL 3, SYNERGY AND SYNGERY VERSITREL SPINAL CORD STIMULATION SYSTEMS
• Classification Name: stimulator, spinal-cord, totally implanted for pain relief
• Generic Name: implantable programmable neurological electrical pulse generator
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P840001
• Supplement Number: S072
• Date Received: 03/05/2004
• Decision Date: 04/15/2004
• Product Code: LGW [ Registered Establishments with LGW ]
• Advisory Committee: Neurology
• Supplement Type: real-time process
• Supplement Reason: change design/components/specifications - material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval to use ealsthane resins as alternate materials to pellethane resins in leads, extensions and accessories. The following leads, extensions and accessories will be affected: model 3487a - pisces quad, model 3887 - pisces quad compact, model 3888 - pisces quad plus, model 3890 - pisces z quad, model 3891 - pisces z quad compact, model 3892 - pisces z quad plus, model 3898 - pisces octad, model 3998 - specify, model 3982a - symmix, model 3861 - temporary screening lead, model 3862 - verify, model 3587a - resume ii, model 3986a resumetl, model 7471 extension, model 7489 extension, model 7495 extension, model 7495lz extension, model 7496 extension, model 7498 extension, model 3550-09 - accessory kit, model 7441 - accessory kit and model 7441nc - accessory kit.