Superion Indirect Decompression System
FDA premarket approval P140004/S033 · decided 2024-08-22
Approval details
- PMA number
- P140004
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- 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
- 2024-06-06
- Decision date
- 2024-08-22
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- approval to manufacture the Superion IDS Instrument kits (Vertiflex Instrument Platform Kit (VIP Kit) and Single Use Instruments Kit (SUI Kit)) at the following alternate manufacturing site: AUSA Medical Devices (Adroit USA, Inc.)
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