Atlas FDA

WOLVERINE Coronary Cutting Balloon

FDA premarket approval P950020/S118 · decided 2022-03-31

Approval details

PMA number
P950020
Supplement
S118
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
WOLVERINE Coronary Cutting Balloon
Generic name
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Applicant
Boston Scientific Corp
Date received
2022-03-03
Decision date
2022-03-31
Days to decision
28 days
Decision code
OK30
Product code
NWX
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Add Galway, Ireland as an additional manufacturing site for the WOLVERINE Monorail (MR) and Over the Wire (OTW) distal outer (monorail only), distal inner, proximal inner and bumper tip components.

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