PMA P000018S024

Device: NOVOSTE BETA-CATH SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S024
Product code: MOU
Decision date: 2002-09-30
Classification: Intravascular Radiation Delivery System
Generic name: Intravascular radiation delivery system
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF THE NOVOSTE BETA-CATH SYSTEM SOURCE TRAIN GOLD MARKERS WHICH INVOLVES THE REMOVAL OF THE ELECTROLESS NICKEL FLASHING PROCESS.

Current openFDA PMA Record#

Device: NOVOSTE BETA-CATH SYSTEM
Applicant: Best Vascular, Inc.
PMA number: P000018
Supplement: S024
Product code: MOU
Generic name: Intravascular radiation delivery system
Decision date: 2002-09-30
Decision code: OK30
Date received: 2002-09-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF THE NOVOSTE BETA-CATH SYSTEM SOURCE TRAIN GOLD MARKERS WHICH INVOLVES THE REMOVAL OF THE ELECTROLESS NICKEL FLASHING PROCESS.