Premarket Approval (PMA)

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.

• Device: HEMASHIELD (R) MICROVEL (R) DOUBLE VELOUR
• Applicant: Maquet Cardiovascular, LLC; 45 Barbour Pond Dr.; Wayne, NJ 07470
• PMA Number: P840029
• Supplement Number: S011
• Date Received: 02/04/1992
• Decision Date: 05/17/1993
• Reclassified Date: 05/10/2001
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No