TRIPOLE 16 AND 16C (C-SERIES) SPINAL CORD STIMULATION LEADS, EXCLAIM SPINAL CORD STIMULATION LEADS, LAMITRODE 4, 44, 44C
FDA premarket approval P010032/S067 · decided 2013-10-15
Approval details
- PMA number
- P010032
- Supplement
- S067
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRIPOLE 16 AND 16C (C-SERIES) SPINAL CORD STIMULATION LEADS, EXCLAIM SPINAL CORD STIMULATION LEADS, LAMITRODE 4, 44, 44C
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2013-01-28
- Decision date
- 2013-10-15
- Days to decision
- 260 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL TO INCREASE THE UPPER LIMIT OF THE GROOVE WIDTH AND DEPTH ON THE PENTA ELECTRODE.
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