|
Device | Spatz3 Adjustable Balloon System |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | Spatz FGIA Inc. 1801 S Perimeter Rd Suite 130 Ft. Lauderdale, FL 33309 |
PMA Number | P190012 |
Supplement Number | S004 |
Date Received | 01/31/2024 |
Decision Date | 02/29/2024 |
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 for preparation of dye solution for package integrity and manufacturing clean room environment |