INTELLANAV OPEN-IRRIGATED ABLATION CATHETER
FDA premarket approval P150005/S005 · decided 2016-07-07
Approval details
- PMA number
- P150005
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INTELLANAV OPEN-IRRIGATED ABLATION CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- Boston Scientific Corp
- Date received
- 2016-04-11
- Decision date
- 2016-07-07
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for design changes to incorporate a magnetic sensor into the Blazer Open Irrigated Ablation Catheter. The device, as modified, will be marketed under the trade name IntellaNav Open-Irrigated Ablation Catheter and is indicated for: The IntellaNav Open-Irrigated Catheter, when used with a Maestro 4000® Radiofrequency (RF) Controller and MetriQ Irrigation Pump, is indicated for:1) cardiac electrophysiological mapping; 2) delivering diagnostic pacing stimuli; and 3) RF ablation of sustain
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510(k) clearances by this applicant
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|---|---|---|
| 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 |