Spatz3 Adjustable Balloon System
FDA premarket approval P190012/S002 · decided 2023-02-15
Approval details
- PMA number
- P190012
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Spatz3 Adjustable Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Spatz Fgia, Inc.
- Date received
- 2022-07-07
- Decision date
- 2023-02-15
- Days to decision
- 223 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Ft. Lauderdale, FL
- Statement
- Approval for adding a new in-house cleanroom to the Spatz manufacturing site at Ha-Tidhar 2 St. Raanana.
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