PROTEGE SYSTEM
FDA premarket approval P010032/S074 · decided 2014-03-21
Approval details
- PMA number
- P010032
- Supplement
- S074
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROTEGE SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2013-12-23
- Decision date
- 2014-03-21
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI IPG TO PROTÉGÉ (MODEL 3789); LABELING MODIFICATIONS TO CHANGE THE NAME OF THE EON MINI LE CHARGE TO PRODIGY CHARGER (MODEL 3730); AND MINOR SOFTWARE MODIFICATIONS TO THE PATIENT PROGRAMMER AND RAPID PROGRAMMER (MODEL 3852) TO RECOGNIZE THE DEVICE WITH THE NEW PROTÉGÉ DEVICE NAME AND MODEL NUMBER.
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510(k) clearances by this applicant
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|---|---|---|
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