Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Cardiva VASCADE Family |
Generic Name | Device, hemostasis, vascular |
Applicant | CARDIVA MEDICAL, INC. 2900 LAKESIDE DRIVE SUITE 160 Santa Clara, CA 95054 |
PMA Number | P120016 |
Supplement Number | S035 |
Date Received | 12/18/2023 |
Decision Date | 01/08/2024 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding a warning to the instructions for use related to retracting the device sleeve to enhance the safe use of the device |
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