Proclaim DRG IPG Clinical Programmer App
FDA premarket approval P150004/S029 · decided 2019-09-17
Approval details
- PMA number
- P150004
- Supplement
- S029
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Proclaim DRG IPG Clinical Programmer App
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-03-21
- Decision date
- 2019-09-17
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for updating the Clinician Programmer Application and Patient Controller Application to support an expanded allowable impedance range for MR Conditional devices entering MRI Mode, and to amend the labeling and software to change the term Program Mode to Dosage and Cycle to Intermittent.
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