Atlas FDA

FLEXTOME CUTTING BALLOON MONORAIL(MR) AND OVER THE WIRE (OTW)

FDA premarket approval P950020/S013 · decided 2008-09-29

Approval details

PMA number
P950020
Supplement
S013
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
FLEXTOME CUTTING BALLOON MONORAIL(MR) AND OVER THE WIRE (OTW)
Generic name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Applicant
Boston Scientific Corp
Date received
2005-09-12
Decision date
2008-09-29
Days to decision
1113 days
Decision code
APPR
Product code
NWX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
APPROVAL FOR MANUFACTURING SITES LOCATED AT BOSTON SCIENTIFIC CORPORATION, IN MAPLE GROVE, MINNESOTA AND PLYMOUTH, MINNESOTA FOR THE MANUFACTURE OF THE BALLOON COMPONENT OF THE DEVICE.

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

RecordFirmDate
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245)Boston Scientific Corp2024-10-18
LUX-Dx II (M302); LUX-Dx II+ (M312) (K231328)Boston Scientific Corp2023-08-19
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary (K152853)Boston Scientific Corp2015-11-20
AXIOS Stent with Electrocautery Enhanced Delivery System (K150692)Boston Scientific Corp2015-08-05
XXL Vascular Balloon Dilatation Catheter (K150303)Boston Scientific Corp2015-06-15
Chariot Guiding Sheath (K150186)Boston Scientific Corp2015-06-05
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820)Boston Scientific Corp2014-10-21