PMA P000022

Device: S7/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Applicant: Medtronic Vascular
PMA number: P000022
Supplement: S003
Product code: MAF
Decision date: 2001-10-02
Generic name: STENT, CORONARY
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF JOINING THE TWO TYPES OF TUBING TO A PROCESS WHERE THE JACKET IS EXTRUDED DIRECTLY ONTO THE HYPOTUBE.

Current openFDA PMA Record

Device: S7/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Applicant: Medtronic Vascular
PMA number: P000022
Supplement: S008
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 2001-10-02
Decision code: OK30
Date received: 2001-09-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS OF JOINING THE TWO TYPES OF TUBING TO A PROCESS WHERE THE JACKET IS EXTRUDED DIRECTLY ONTO THE HYPOTUBE.