ANCURE(TM) ENDOGRAFT(R) SYSTEM
FDA premarket approval P990017/S004 · decided 2000-01-07
Approval details
- PMA number
- P990017
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ANCURE(TM) ENDOGRAFT(R) SYSTEM
- Applicant
- Boston Scientific Corp
- Date received
- 1999-12-14
- Decision date
- 2000-01-07
- Days to decision
- 24 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for labeling changes under 21 CFR 814.39(d)
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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 |
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| 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 |