PMA P150028S003

Device: Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
Applicant: NuMED, Inc.
PMA number: P150028
Supplement: S003
Product code: PNF
Decision date: 2018-07-20
Classification: Aortic Stent
Generic name: Aortic stent
Approval order statement: Approval for the addition of a quality control inspection step to the Mounted CP Stent manufacturing process.

Current openFDA PMA Record#

Device: Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent)
Applicant: NuMED, Inc.
PMA number: P150028
Supplement: S003
Product code: PNF
Generic name: Aortic stent
Decision date: 2018-07-20
Decision code: APPR
Date received: 2018-06-27
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of a quality control inspection step to the Mounted CP Stent manufacturing process.