Vercise Genus R32, Vercise Genus R16
FDA premarket approval P150031/S050 · decided 2022-06-23
Approval details
- PMA number
- P150031
- Supplement
- S050
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Vercise Genus R32, Vercise Genus R16
- Generic name
- Stimulator, electrical, implanted, for parkinsonian symptoms
- Applicant
- Boston Scientific Corp
- Date received
- 2022-06-13
- Decision date
- 2022-06-23
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- NHL
- 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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510(k) clearances by this applicant
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|---|---|---|
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| WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853) | Boston Scientific Corp | 2015-11-20 |
| AXIOS Stent with Electrocautery Enhanced Delivery System (K150692) | Boston Scientific Corp | 2015-08-05 |
| XXL Vascular Balloon Dilatation Catheter (K150303) | Boston Scientific Corp | 2015-06-15 |
| Chariot Guiding Sheath (K150186) | Boston Scientific Corp | 2015-06-05 |
| 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 |