PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS
FDA premarket approval P030017/S203 · decided 2014-10-02
Approval details
- PMA number
- P030017
- Supplement
- S203
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Boston Scientific Corp
- Date received
- 2014-09-02
- Decision date
- 2014-10-02
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A LABELING CHANGE TO BE MADE TO THE PRECISION AND PRECISION SPECTRA MANUALS. THE REQUESTED CHANGE ADDS SUPPLEMENTAL INFORMATION TO THE ADVERSE EVENTS SECTION OF THE MANUALS IN ORDER TO PROVIDE ADDITIONAL DETAILS ON THE POSSIBILITY OF THE FORMATION OF REACTIVE TISSUE AROUND THE LEAD IN THE EPIDURAL SPACE WHICH MAY RESULT IN DELAYED ONSET OF SPINAL CORD COMPRESSION AND NEUROLOGICAL/SENSORY DEFICIT INCLUDING PARALYSIS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245) | Boston Scientific Corp | 2024-10-18 |
| LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328) | Boston Scientific Corp | 2023-08-19 |
| 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 |