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 | RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P140012 |
Supplement Number | S004 |
Date Received | 12/01/2015 |
Decision Date | 12/31/2015 |
Withdrawal Date
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07/23/2019 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF VESTA, INC., AS A SECOND SOURCE SUPPLIER OF THE BALLOON SHELL (P/N 03-0238). |
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