|
Device | GFX 2 OVER-THE-WIRE CORONARY STSENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P970035 |
Supplement Number | S016 |
Date Received | 04/26/1999 |
Decision Date | 05/14/1999 |
Withdrawal Date
|
10/18/2010 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |