PMA P970035S016

Device: GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S016
Product code: MAF
Decision date: 1999-05-14
Generic name: STENT, CORONARY
Approval order statement: The 30-Day Notice requested that GFX(R) ring components annealed at 985 degrees Celsius for 20 minutes be utilized for the manufacturing of the GFX2 stent component. The change is being requested in order to utilize the existing inventory of GFX ring components for the manufacture of GFX2 stent.

Current openFDA PMA Record

Device: GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM
Applicant: Medtronic, Ireland
PMA number: P970035
Supplement: S016
Product code: MAF
Generic name: STENT, CORONARY
Decision date: 1999-05-14
Decision code: OK30
Date received: 1999-04-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-Day Notice requested that GFX(R) ring components annealed at 985 degrees Celsius for 20 minutes be utilized for the manufacturing of the GFX2 stent component. The change is being requested in order to utilize the existing inventory of GFX ring components for the manufacture of GFX2 stent.