Atlas FDA

Proclaim Dorsal Root Ganglion (DRG) External Programmer Apps

FDA premarket approval P150004/S020 · decided 2018-07-19

Approval details

PMA number
P150004
Supplement
S020
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Proclaim Dorsal Root Ganglion (DRG) External Programmer Apps
Generic name
Dorsal root ganglion stimulator for pain relief
Applicant
ABBOTT MEDICAL
Date received
2018-02-13
Decision date
2018-07-19
Days to decision
156 days
Decision code
APPR
Product code
PMP
Advisory committee
Neurology
Expedited review
No
Location
Plano, TX
Statement
Approval for:1) P140009/S037: MR Conditional labeling, Firmware version 1.3, and Clinician Programmer and Patient Controller Apps version 3.7 (DBS MRI mode, DBS shared frequency mode, DBS Multistim Programming, DBS Monopolar Survey Mode, and minor software changes); and2) P010032/S141 and P150004/S20: Firmware version 1.3 and Clinician Programmer and Patient Controller Apps version 3.7 (minor software changes).

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