Spatz3 Adjustable Balloon System
FDA premarket approval P190012/S004 · decided 2024-02-29
Approval details
- PMA number
- P190012
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Spatz3 Adjustable Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Spatz Fgia, Inc.
- Date received
- 2024-01-31
- Decision date
- 2024-02-29
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Ft. Lauderdale, FL
- Statement
- for preparation of dye solution for package integrity and manufacturing clean room environment
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