Proclaim SCS IPG, Infinity DBS IPG, and Proclaim DRG IPG
FDA premarket approval P140009/S054 · decided 2020-01-10
Approval details
- PMA number
- P140009
- Supplement
- S054
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Proclaim SCS IPG, Infinity DBS IPG, and Proclaim DRG IPG
- Generic name
- Stimulator, electrical, implanted, for parkinsonian tremor
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-12-13
- Decision date
- 2020-01-10
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MHY
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Addition of an alternate Tier II supplier of the crystal used in the Orion family IPG devices.
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