510(k) K122459
- Device
- PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K122459
- Product code
- OTP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-12-13
- Date received
- 2012-08-13
- Regulation
- 884.5980
- Classification name
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 3
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHELLE BERRY
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 1018233
- 3004838863
- 2529647
- 1048735
Source Documents#
Other 510(k) Records For Product Code OTP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121612 | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION | American Medical Systems | 2012-07-20 |
| K112842 | AMS ELEVATE PC | American Medical Systems, Inc. | 2011-10-25 |
| K103426 | LITE PELVIC FLOOR REPAIR KITS | Boston Scientific Corp | 2011-09-14 |
| K112386 | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM | Coloplast Corp. | 2011-09-08 |
| K102815 | SURELIFT PROLAPSE SYSTEM | Neomedic International | 2011-07-07 |
| K111118 | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | American Medical Systems | 2011-07-01 |
| K092207 | RESTORELLE POLYPROPYLENE MESH | Mpathy Medical Devices, Inc. | 2009-08-04 |
| K091131 | PELVIC FLOOR REPAIR SYSTEM | Boston Scientific | 2009-05-08 |
| K083499 | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS | Coloplast A/S | 2009-05-08 |
| K090713 | ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP | American Medical Systems, Inc. | 2009-04-02 |
| K083722 | ASCEND | Caldera Medical, Inc. | 2009-03-31 |
| K083839 | AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM | C.R. Bard, Inc. | 2009-01-15 |
| K082677 | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE | American Medical Systems, Inc. | 2008-12-23 |
| K082387 | APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM | American Medical Systems | 2008-12-04 |
| K082730 | AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE | American Medical Systems, Inc. | 2008-11-26 |
Legacy Summary#
summary
FDA Review#
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