PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
FDA premarket approval P030017/S251 · decided 2016-06-07
Approval details
- PMA number
- P030017
- Supplement
- S251
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2016-03-14
- Decision date
- 2016-06-07
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for adding an alternate qualified supplier for the Coil Connector that is used in the assembly of the Precision M1 and M8 Adaptors.
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|---|---|---|
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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 |