|
Device | TALENT OCCLUDER WITH OCCLUDER DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P070027 |
Supplement Number | S045 |
Date Received | 09/18/2015 |
Decision Date | 10/15/2015 |
Withdrawal Date
|
03/06/2017 |
Product Code |
MIH |
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 IMPLEMENTATION OF A NEW INTERNAL PROCESS CHALLENGE DEVICE (IPCD) INOCULATION METHOD FOR BIANNUAL STERILIZATION REQUALIFICATION. |