Atlas FDA

FLEXTOME CUTTING BALLOON MONORAIL

FDA premarket approval P950020/S019 · decided 2006-10-19

Approval details

PMA number
P950020
Supplement
S019
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
FLEXTOME CUTTING BALLOON MONORAIL
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Boston Scientific Corp
Date received
2006-09-19
Decision date
2006-10-19
Days to decision
30 days
Decision code
OK30
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
CHANGE IN THE STERILITY DOSE AUDIT PROCEDURES FROM VD MAX TO METHOD 1, WITH CORRESPONDING CHANGES IN MINIMUM RADIATION STERILIZATION DOSE AND THE NUMBER OF QUARTERLY STERILIZATION DOSE AUDITS.

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