AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA 510(k) clearance K111118 · decided 2011-07-01
Clearance details
- K-number
- K111118
- Device name
- AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
- Applicant
- American Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2011-04-21
- Decision date
- 2011-07-01
- Days to decision
- 71 days
- Clearance type
- Special
- Product code
- OTP
- Device class
- 3
- Regulation number
- 884.5980
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.