PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM
FDA premarket approval P030017/S269 · decided 2017-05-31
Approval details
- PMA number
- P030017
- Supplement
- S269
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2016-11-28
- Decision date
- 2017-05-31
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for expanding magnetic conditional labeling for the Precision Montage MRI Spinal Cord Stimulation System to include existing BSN SCS Leads.
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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 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |