WaveWriter Alpha, WaveWriter Alpha 16
FDA premarket approval P030017/S350 · decided 2022-06-23
Approval details
- PMA number
- P030017
- Supplement
- S350
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- WaveWriter Alpha, WaveWriter Alpha 16
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2022-06-13
- Decision date
- 2022-06-23
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Changes to update the Laser Excise process by adding a pre-excise phase, modifying the laser focal point, and shifting the position of the laser closer to the excised edge during the ablation phase during the manufacturing of the Printed Circuit Board assembly (PCBA) of the Implantable Pulse Generator (IPG) at the Boston Scientific Clonmel manufacturing site.
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| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
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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 |