Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Specify,
Medtronic Neuromodulation · Stimulator, spinal-cord, totally implanted for pain relief · Neurology
Open FDA's page for this record- PMA number
- P840001
- Supplement number
- S636
- Applicant
- Medtronic Neuromodulation
- Street 1
- 7000 Central Ave., NE
- City
- Minneapolis
- State
- MN
- Zip
- 55432
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Trade name
- Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Specify,
- Product code
- LGW
- Advisory committee
- NE
- Advisory committee description
- Neurology
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-30
- Decision date
- 2026-10-30
- Decision code
- OK30
- Ao statement
approval for the following three changes: 1) Adding a new surface mount technology (SMT) production line.2) Revision of the SMT manufacturing process sequence to perform automated optical inspection immediately following each SMT assembly stage.3) Addition of an equivalent solder paste inspection system and addition of a qualified de-paneling machine for PCBA production
- Harmonized identifiers (openFDA)
- Device name
- Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 2182291, 2133772, 1627487, 3027063190, 3007882731, 3007616088, 3021836309, 3010052483, 3018094310, 3012693387, 3009380063, 3015200795, 3010326622, 3010086866, 3003335547, 3010966701, 2134604, 9610139, 3003477135, 3003120897, 2135338, 3014507028, 1035166, 3004593495, 3019807891, 2648729, 3020969413, 3038429246, 3006630150, 3013973539, 3008514029, 3010972758, 3004209178, 3005160949, 3016618265, 9616693, 3008988055, 2133810, 2182207, 2030624 +15 more
- FEI number
- 2182291, 1627487, 3027063190, 3007882731, 3000209794, 3021836309, 3000203466, 3007616088, 3010052483, 3018094310, 3012693387, 3009380063, 3015200795, 3010326622, 3010086866, 3003335547, 3010966701, 3000206435, 3003477135, 3003120897, 3014507028, 1035166, 3004593495, 3004369318, 3005846326, 3019807891, 3005700659, 2648729, 3020969413, 3038429246, 3003574398, 3006630150, 3013973539, 3008514029, 3010972758, 3005160949, 3002623849, 3016618265, 3008988055, 3006705815 +15 more