Proclaim SCS Neurostimulation System FW
FDA premarket approval P010032/S148 · decided 2019-05-03
Approval details
- PMA number
- P010032
- Supplement
- S148
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Proclaim SCS Neurostimulation System FW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-01-23
- Decision date
- 2019-05-03
- Days to decision
- 100 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for an update to the firmware version to v1.3 for the legally marketed family Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generators.
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