|
Device | CRYOABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MOUNDS VIEW, MN 55112 |
PMA Number | P020045 |
Supplement Number | S067 |
Date Received | 07/21/2015 |
Decision Date | 09/28/2015 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR PRINTED CIRCUIT BOARD DESIGN AND ASSOCIATED LABELING CHANGES FOR THE AUTO CONNECTION BOX AND ECG CABLE. |