PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS
FDA premarket approval P110010/S090 · decided 2014-09-17
Approval details
- PMA number
- P110010
- Supplement
- S090
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS
- Generic name
- Coronary drug-eluting stent
- Applicant
- Boston Scientific Corp
- Date received
- 2014-06-19
- Decision date
- 2014-09-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NIQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR CHANGES TO THE ACCESSORY KIT (REMOVAL OF CLIPIT HYPOTUBE CLIPS, SUBSTITUTION OF FLUSHING NEEDLE MANUFACTURED BY NEW VENDOR, MODIFICATION OF CARRIER TUBE CLIP AND UPDATE TO THE EDFU) AND IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE OR DOCUMENTED SILENT ISCHEMIA DUE TO DE NOVO LESIONS IN NATIVE CORONARY ARTERIES >=2.25 MM TO <=4.00 MM IN DIAMETER IN LESIONS <=34 MM IN LENGTH.
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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 |