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 | RelayPro Thoracic Stent-Graft System |
Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
Applicant | Bolton Medical, Inc.799 International Parkwaysunrise, FL 33325 PMA NumberP200045 Supplement NumberS003 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-07-12 |
Decision Date | 2022-08-11 |
PMA | P200045 |
Supplement | S003 |
Product Code | MIH |
Advisory Committee | Cardiovascular |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | Bolton Medical, Inc. 799 International Parkway sunrise, FL 33325 PMA NumberP200045 Supplement NumberS003 Date Received07/12/2022 Decision Date08/11/2022 Product Code MIH Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement replacement Of Manufacturing Equipment For A Delivery System Component Of RelayPro And RelayPlus Thoracic Stent-Graft Systems |
Supplement Number | Date | Supplement Type |
---|---|---|
P200045 | Original Filing | |
S003 | 2022-07-12 | 30-day Notice |
S002 | ||
S001 | 2021-09-03 | Normal 180 Day Track No User Fee |