# K972043: Medtronic Model 3273/3274 RF Receiver and Model 3629/3630 Screener

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Aug 22, 1997 after 81 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904409 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934065: Medtronic Mattrix 3271/3272 Neurostimulation System, Medtronic Vascular (1995) Summary page 1.
- K904409: Medtronic (R) Model 3470 X-Trel (TM) Receiver, Medtronic Vascular (1991) Summary page 1.
- K903690: Medtronic (R) Model 3625 Screener, Medtronic Vascular (1991) Summary page 2.

## Cited in the summary but kept off the family tree
- K823130: Model 3462B RF Receiver. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
Model 3273/3274 Receiver and Model 3626/3630 Screener indicated for use for epidural spinal cord stimulation (SCS) and peripheral nerve stimulation (PNS), as an aid in the treatment of chronic intractable pain of the trunk and/or limbs.

Source page: https://510kreport.com/device/K972043
Methodology: https://510kreport.com/methodology