Atlas FDA

PAH

20 FDA 510(k) clearances · Product code

87 daysmedian time to decision
373 days90th percentile
20clearances measured

FDA profile

Official device name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Flags
Implant
FDA definition
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Adverse events (MAUDE)
2021: 318 · 2022: 159 · 2023: 154 · 2024: 287 · 2025: 244 · 2026: 201
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (K242473)Coloplast Corp.2024-10-18
Altis Single Incision Sling System (K221874)Coloplast A/S2023-02-15
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack (K191416)Caldera Medical, Inc.2020-02-07
ALTIS SINGLE INCISION CLING SYSTEM (K121562)Coloplast A/S2012-11-05
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING (K123179)C.R. Bard, Inc.2012-11-02
MINIARC PRO SINGLE-INCISION SLING SYSTEM (K121641)American Medical Systems2012-09-07
OPHIRA MINI SLING SYSTEM (K110420)Promedon S.A2012-05-08
DESARA MINI (K103418)Caldera Medical, Inc.2011-11-30
MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 (K100807)American Medical Systems, Inc.2010-06-07
AJUST ADJUSTABLE SINGLE INCISION SLING (K092607)C.R. Bard, Inc.2009-11-20
MINITAPE URETHRAL SLING (K091180)Mpathy Medical Devices, Ltd.2009-07-14
BOSTON SCIENTIFIC SURGICAL MESH (K081275)Boston Scientific Corp2008-08-27
MINITAPE URETHRAL SLING (K073646)Mpathy Medical Devices, Ltd.2008-02-25
AMS MINIARC SLING SYSTEM (K073703)American Medical Systems, Inc.2008-01-30
AMS MINIARC SLING SYSTEM (K071902)American Medical Systems, Inc.2007-08-24
AMS SINGLE INCISION SLING SYSTEM (SIS-0) (K070065)American Medical Systems, Inc.2007-03-01
NEEDLELESS SLING (K063136)Specialities Remeex International, S.L.2006-12-19
GYNECARE TVT SECUR SYSTEM (K052401)ETHICON, Inc.2005-11-28
GYNE IDEAS MINITAPE RP DEVICE (K023898)Gyne Ideas , Ltd.2003-06-18
HERNIAMESH T-SLING (K020652)Herniamesh2002-05-15

Track PAH automatically

Every clearance here is in the API, with alerts when new ones post.