PMP
FDA premarket approval P150004/S006 · decided 2017-02-03
Approval details
- PMA number
- P150004
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PMP
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-11-07
- Decision date
- 2017-02-03
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval of an updated version (v 3.4) of Clinician Programmer and Patient Controller software to enable the Surgery Mode and Device Status Check features in the Proclaim Elite, Infinity, and Proclaim DRG family of implanted pulse generators (IPGs).
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |