CHILLI COOLED ABLATION SYSTEM
FDA premarket approval P980003/S025 · decided 2011-04-08
Approval details
- PMA number
- P980003
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CHILLI COOLED ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 2010-10-18
- Decision date
- 2011-04-08
- Days to decision
- 172 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- APPROVAL FOR TEN DESIGN CHANGES TO THE CIRCUCOOL MODEL 8005 PUMP SYSTEM TO ADDRESS STOPPAGE AND MOTOR NOISE COMPLAINTS. THESE CHANGES INCLUDE: 1) CHANGING A SCHOTKY DIODE FROM ON SEMICONDUCTOR¿S 1N5822 (40V MAXIMUM REVERSE VOLTAGE) TO ON SEMICONDUCTOR¿S MBR360 (60V MAXIMUM REVERSE VOLTAGE). 2) ADDITION OF A 33.3V VOLTAGE SUPPRESSOR (ON SEMICONDUCTOR P6KE39AG) ACROSS MOTOR TERMINALS AT THE MOTOR. 3) DIMENSIONAL AND TOLERANCE REVISIONS TO THE ROLLER SLEEVE, SHAFT ROTOR AND ROLLER COMPONENTS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |