Superion Indirect Decompression System
FDA premarket approval P140004/S029 · decided 2023-01-06
Approval details
- PMA number
- P140004
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Superion Indirect Decompression System
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2022-12-08
- Decision date
- 2023-01-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Introduce an additional cleanroom facility at your Clonmel Ireland manufacturing facility.
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