CUTTING BALLOON
FDA premarket approval P950020/S005 · decided 2002-07-17
Approval details
- PMA number
- P950020
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CUTTING BALLOON
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Boston Scientific Corp
- Date received
- 2002-05-22
- Decision date
- 2002-07-17
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR THE 6 MM CUTTING BALLOON. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CUTTING BALLOON MONORAIL/OTW (6 MM) AND IS INDICATED FOR DILATATION OF STENOSIS IN CORONARY ARTERIES FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION IN THOSE CIRCUMSTANCES WHERE A HIGH PRESSURE BALLOON RESISTANT LESION IS ENCOUNTERED. IN ADDITION, THE TARGET LESION SHOULD POSSESS THE FOLLOWING CHARACTERISTICS: DISCRETE (<= 15 MM IN LENGTH) OR TUBULAR (10 TO 20 MM IN LENGTH); WITH A REFERENCE V
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 |