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 | LIFEVEST WCD 3000 |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S008 |
Date Received | 08/11/2006 |
Decision Date | 10/31/2007 |
Product Code |
MVK |
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 A CHANGE IN THE BATTERY PACK PCA ARTWORK, ADDITION OF 100-OHM RESISTOR AT U3 PIN 1, AND A CHANGE OF THE DOUBLE-SIDED PRESSURE SENSITIVE ADHESIVE (PSA) TAPE. |
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