PROTEGE MRI NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S085 · decided 2015-04-22
Approval details
- PMA number
- P010032
- Supplement
- S085
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROTEGE MRI NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-09-29
- Decision date
- 2015-04-22
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR THE PROTEGE MRI IPG MODEL 3 771 AND PATIENT PROGRAMMER (PPGR) MODEL 3853 WHICH HAVE UPDATED LABELING THAT WILL ALLOW PATIENTS TO UNDERGO MRI SCANS OF THE HEAD AND EXTREMITIES PER THE DEFINED CONDITIONS.
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