Superion Indirect Decompression System (IDS)
FDA premarket approval P140004/S025 · decided 2021-08-26
Approval details
- PMA number
- P140004
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Superion Indirect Decompression System (IDS)
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2021-07-30
- Decision date
- 2021-08-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Distribute the device incorporating the change as requested in this supplement. This change applies to the final assembly of the Superion Indirect Decompression System (IDS) device. The following manufacturing facility is affected by the change: Boston Scientific Limited, Cashel Rd, ClonmelCo, Tipperary, Ireland.
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