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 | VENASEAL CLOSURE SYSTEM |
Generic Name | Agent, occluding, vascular, permanent |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P140018 |
Supplement Number | S002 |
Date Received | 06/27/2016 |
Decision Date | 07/27/2016 |
Product Code |
PJQ |
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 Implementation of an alternative test method for determination of adhesive stabilizer concentration in the n-butyl cyanoacrylate (nBCA) monomer at incoming inspection as well as in the VenaSeal adhesive formulation. |
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