WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System
FDA premarket approval P030017/S381 · decided 2025-03-17
Approval details
- PMA number
- P030017
- Supplement
- S381
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2024-12-20
- Decision date
- 2025-03-17
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval of PMA 180-day supplement, which requested approval for adding 3T Magnetic Resonance (MR) conditional labeling to the implanted components of the WaveWriter Alpha Spinal Cord Stimulation (SCS) System and WaveWriter Alpha Prime SCS System for head and lower extremities
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |