|
Device | Tendril MRI Steroid Eluting Cardiac Leads |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P140033 |
Supplement Number | S045 |
Date Received | 05/01/2019 |
Decision Date | 05/29/2019 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Manufacturing process improvements for monolithic controlled release devices used in Tendril MRI1200M leads. |