CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)

FDA premarket approval P150028 · decided 2016-03-25

Approval details

PMA number

P150028

Trade name

CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)

Generic name

Aortic stent

Applicant

NuMED, Inc.

Date received

2015-08-05

Decision date

2016-03-25

Days to decision

233 days

Decision code

APPR

Product code

PNF

Advisory committee

Cardiovascular

Expedited review

Yes

Location

Hopkinton, NY

Statement

Approval for the Cheatham Platinum (CP) Stent System, including the CP Stent, Mounted CP Stent, Covered CP Stent, and Covered Mounted CP Stent. The CP Stent and Mounted CP Stent are indicated for use in the treatment of native and/or recurrent coarctation of the aorta involving a compliant aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery and balloon angioplasty is contraindicated or predicted to be ineffective.The Cov

510(k) clearances by this applicant