IMPLANTABLE PULSE GENERATOR SYSTEM
FDA premarket approval P010032/S034 · decided 2010-11-19
Approval details
- PMA number
- P010032
- Supplement
- S034
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMPLANTABLE PULSE GENERATOR SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-10-20
- Decision date
- 2010-11-19
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR THE ADDITION OF CRIMP RINGS IN THE STRAIN RELIEFS OF THE EXTERNAL PROGRAMMING WAND CABLE TO IMPROVE RELIABILITY.
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