PMA P980001S012

Device: NIR PREMOUNTED STENT SYSTEMS
Applicant: Boston Scientific Corp
PMA number: P980001
Supplement: S012
Decision date: 2000-03-20
Approval order statement: Approval for a modification to the Indications for Use statement and the Instructions for Use (IFU) to include the results of the nine-month follow-up of the NIRVANA clinical trial for the NIR ON Ranger and NIR Primo Premounted Stent Systems.

Current openFDA PMA Record

Device: NIR PREMOUNTED STENT SYSTEMS
Applicant: Boston Scientific Corp
PMA number: P980001
Supplement: S012
Decision date: 2000-03-20
Decision code: APPR
Date received: 1999-09-20
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a modification to the Indications for Use statement and the Instructions for Use (IFU) to include the results of the nine-month follow-up of the NIRVANA clinical trial for the NIR ON Ranger and NIR Primo Premounted Stent Systems.