Prodigy Leads and Extension Insertion Tool
FDA premarket approval P010032/S124 · decided 2017-01-09
Approval details
- PMA number
- P010032
- Supplement
- S124
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Prodigy Leads and Extension Insertion Tool
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2016-10-11
- Decision date
- 2017-01-09
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for expanding the compatibility of an optional accessory, the Lead and Extension Insertion Tool (Model 1803), for use with approved SJM Implantable Pulse Generators (IPGs) and compatible leads, extensions, and adapters.
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