AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone, and the AMS Ambicor Inflatable Penile Prosthesis
FDA premarket approval P000053/S107 · decided 2019-09-20
Approval details
- PMA number
- P000053
- Supplement
- S107
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone, and the AMS Ambicor Inflatable Penile Prosthesis
- Generic name
- Device, incontinence, mechanical/hydraulic
- Applicant
- Boston Scientific Corp
- Date received
- 2019-08-22
- Decision date
- 2019-09-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- EZY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Change to the number of nitrogen gas washes performed as part of ethylene oxide (EO) sterilization Cycle 101 from three to six.
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510(k) clearances by this applicant
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|---|---|---|
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| EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679) | Boston Scientific Corp | 2015-05-29 |
| JAGWIRE HIGH PERFORMANCE GUIDWIRE (K141820) | Boston Scientific Corp | 2014-10-21 |