ULTRA2 CUTTING BALLOON MONORAIL(MR)
FDA premarket approval P950020/S012 · decided 2005-03-16
Approval details
- PMA number
- P950020
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ULTRA2 CUTTING BALLOON MONORAIL(MR)
- Generic name
- Catheter, angioplasty, peripheral, transluminal
- Applicant
- Boston Scientific Corp
- Date received
- 2004-11-08
- Decision date
- 2005-03-16
- Days to decision
- 128 days
- Decision code
- APPR
- Product code
- LIT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR MANUFACTURING SITES LOCATED AT INTERVENTIONAL TECHNOLOGIES EUROPE, LTD., DONEGAL, IRELAND AND EBIS IOTRON, LTD., OXON, GREAT BRITAIN.
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 |