|
Device | RF Conductr, RF Contactr, RF Marinr, and RF Enhancr II |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P930029 |
Supplement Number | S067 |
Date Received | 08/31/2020 |
Decision Date | 09/25/2020 |
Product Code |
LPB |
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 Add the incoming inspection testing for Metallographic Interpretation and Metallographic Sample Preparation (Cross Section) at the MPROC Juncos facility. |