Superion Indirect Decompression System
FDA premarket approval P140004/S024 · decided 2020-09-15
Approval details
- PMA number
- P140004
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Superion Indirect Decompression System
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2020-08-24
- Decision date
- 2020-09-15
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for an alternate manufacturing site named Boston Scientific Limited located at Cashel Road, Clonmel, Ireland for sterile packaging and final packaging.
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