Product code OTP— Obstetrics/Gynecology
AMS APOGEE VAULT SUSPENSION SYSTEM
- Classification name
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- Device class
- Class 3
- Regulation
- 21 CFR 884.5980
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 31
- First cleared
- Most recent
FDA classification definition
“Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally”
Market context for product code OTP
FDA has cleared devices under product code OTP between 2003 and 2012, filed by 14 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.
Clearances per year
- 2012
- 2011
- 2009
- 2008
- 2007
- 2005
- 2004
- 2003
Top applicants under product code OTP
Adverse events under product code OTP
product code OTP- Injury
- 1,061
- Total
- 1,061
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code OTP
- K122459 — PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
- K121612 — ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
- K112842 — AMS ELEVATE PC
- K103426 — LITE PELVIC FLOOR REPAIR KITS
- K112386 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM
- K102815 — SURELIFT PROLAPSE SYSTEM
- K111118 — AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
- K092207 — RESTORELLE POLYPROPYLENE MESH
- K083499 — EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS
- K091131 — PELVIC FLOOR REPAIR SYSTEM
- K090713 — ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
- K083722 — ASCEND
- K083839 — AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
- K082677 — AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
- K082387 — APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
- K082730 — AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
- K081710 — APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
- K082571 — AVAULTA SUPPORT SYSTEM
- K081048 — PINNACLE PELVIC FLOOR REPAIR KIT II
- K071512 — GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
- K080185 — AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM
- K072951 — PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
- K071957 — PINNACLE PELVIC FLOOR REPAIR KITS
- K063712 — AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM
- K063562 — GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
- K053414 — MENTOR NOVASILK MESH
- K051503 — UGYTEX SUAL KNIT MESH
- K040623 — AMS PERIGEE SYSTEM
- K040537 — AMS APOGEE VAULT SUSPENSION SYSTEM
- K040521 — MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
- K033636 — AMS LARGE PORE POLYPROPYLENE MESH
Data sourced from openFDA. This site is unofficial and independent of the FDA.