RAPID PROGRAMMER
FDA premarket approval P010032/S053 · decided 2012-07-31
Approval details
- PMA number
- P010032
- Supplement
- S053
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RAPID PROGRAMMER
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-06-01
- Decision date
- 2012-07-31
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR UPGRADING THE RAPID PROGRAMMER SOFTWARE USED IN THE GENESIS AND EON FAMILY NEUROMODULATION STIMULATORS FROM VERSION 3.3 (MODEL 3831 AND 3832) TO VERSION 3.4 (MODEL 3834).
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