WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE)
FDA premarket approval P950020/S072 · decided 2016-08-18
Approval details
- PMA number
- P950020
- Supplement
- S072
- Supplement type
- Normal 180 Day Track
- Trade name
- WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE)
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Applicant
- Boston Scientific Corp
- Date received
- 2016-01-29
- Decision date
- 2016-08-18
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- NWX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for updates to the atherotomes, adhesive, balloon catheter platform, device packaging and the sterilization process. The device, as modified, will be marketed under the trade name WOLVERINE Coronary Cutting Balloon (Monorail & Over-The-Wire) and is indicated for dilatation of stenoses 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 th
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 |