Precision Montage and Precision Montage MRI Spinal Cord Stimulator Systems
FDA premarket approval P030017/S342 · decided 2020-09-30
Approval details
- PMA number
- P030017
- Supplement
- S342
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Precision Montage and Precision Montage MRI Spinal Cord Stimulator Systems
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2020-08-31
- Decision date
- 2020-09-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Change in the electrical resistance testing specification and an update to the supporting test equipment software.
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510(k) clearances by this applicant
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|---|---|---|
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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 |
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