Atlas FDA

Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems

FDA premarket approval P010032/S191 · decided 2023-05-10

Approval details

PMA number
P010032
Supplement
S191
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Applicant
ABBOTT MEDICAL
Date received
2022-09-02
Decision date
2023-05-10
Days to decision
250 days
Decision code
APPR
Product code
LGW
Advisory committee
Neurology
Expedited review
No
Location
Plano, TX
Statement
Approval for expanding the indications to include non-surgical back pain (NSBP) for the tonic and BurstDR stimulation modes, and diabetic peripheral neuropathy (DPN) of the lower extremities for the tonic stimulation mode, for the Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems.

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

510(k) clearances by this applicant

RecordFirmDate
EnSite™ X EP System (K262006)Abbott Medical2026-07-15
Amplatzer TorqVue Exchange System (K261631)Abbott Medical2026-06-17
OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) (K253459)ABBOTT MEDICAL2026-04-24
EnSite™ X EP System (K260212)ABBOTT MEDICAL2026-04-20
Disposable Radiofrequency Cannula (K253907)ABBOTT MEDICAL2026-04-16
Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (K260499)ABBOTT MEDICAL2026-03-13
Armada™ 14 NC PTA Catheter (K252512)ABBOTT MEDICAL2026-02-13
Assert-IQ (DM5100) (K253516)ABBOTT MEDICAL2025-12-18