PMA P150028S007

Device: CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42
Applicant: NuMED, Inc.
PMA number: P150028
Supplement: S007
Product code: PNF
Decision date: 2026-07-06
Classification: Cardiovascular
Generic name: Aortic stent
Approval order statement: approval for a manufacturing site located at Sterigenics U.S., LLC, 84 Park Road, Queensbury, NY 12804 as a contract sterilization facility, and modifications to reduce the ethylene oxide concentration at the existing contract sterilization facility at Cosmed Group (Lynx Medical) at 2205 East 33rd Street, Erie, PA, 16510

Current openFDA PMA Record#

Device: CP Stent (Model 425), Covered CP Stent (Model 427), Mounted CP Stent (Model 426), Covered and Mounted CP Stent (Model 42
Applicant: NuMED, Inc.
PMA number: P150028
Supplement: S007
Product code: PNF
Generic name: Aortic stent
Decision date: 2026-07-06
Decision code: APPR
Date received: 2025-07-21
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at Sterigenics U.S., LLC, 84 Park Road, Queensbury, NY 12804 as a contract sterilization facility, and modifications to reduce the ethylene oxide concentration at the existing contract sterilization facility at Cosmed Group (Lynx Medical) at 2205 East 33rd Street, Erie, PA, 16510