| 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 | ORBERA Intragastric Balloon System |
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| Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
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| Applicant | Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 |
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| PMA Number | P140008 |
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| Supplement Number | S019 |
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| Date Received | 06/08/2020 |
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| Decision Date | 12/02/2020 |
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| Product Code |
LTI |
| Advisory Committee |
Gastroenterology/Urology |
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| Supplement Type | Normal 180 Day Track No User Fee |
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| Supplement Reason | Labeling Change - PAS |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the ORBERATM PAS (OPAS-001.0. The OPAS-001 is a prospective, open-label, single-arm study to evaluate the safety and effectiveness of ORBERA for weight reduction in obese adults 22 years and older with a BMI of 30-40 kg/m2. This is a 52-week study in which subjects will be treated during the first 26 weeks with ORBERA in conjunction with a behavioral modification program, followed by 26 weeks of behavioral modification program alone.A total of 284 subjects will be enrolled at 10 to 20 US sites to yield 255 subjects implanted with ORBERA (assuming a 10% screen failure rate). Based on an estimated attrition rate of 10% through week 26 and 20% through week 52, the expected number of evaluable subjects is 230 subjects at 26 weeks and 204 subjects at 52 weeks. A sample size of 255 implanted subjects will provide 80% power to test the hypothesis that the rate of device- and/or procedure-related serious adverse events (SAEs) is less than 15% at 26 weeks. |
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