PMA P970035S009

Device: MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S009
Product code: MAF
Decision date: 1998-11-17
Generic name: STENT, CORONARY
Approval order statement: The 30-day Notice requested a change int he current Thermal Transfer Printing on the Strain Relief to Ink Jet Printing on the Proximal Two-arm Luer Adapter.

Current openFDA PMA Record

Device: MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S009
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1998-11-17
Decision code: OK30
Date received: 1998-10-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day Notice requested a change int he current Thermal Transfer Printing on the Strain Relief to Ink Jet Printing on the Proximal Two-arm Luer Adapter.