ADIANA PERMANENT CONTRACEPTION SYSTEM
FDA premarket approval P070022 · decided 2009-07-06
Approval details
- PMA number
- P070022
- Trade name
- ADIANA PERMANENT CONTRACEPTION SYSTEM
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Hologic, Inc.
- Date received
- 2007-08-10
- Decision date
- 2009-07-06
- Days to decision
- 696 days
- Decision code
- APWD
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Malborough, MA
- Statement
- APPROVAL FOR THE ADIANA PERMANENT CONTRACEPTION SYSTEM. THE DEVICE IS INDICATED FOR WOMEN WHO DESIRE PERMANENT BIRTH CONTROL (FEMALE STERILIZATION) BY OCCLUSION OF THE FALLOPIAN TUBES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CoolSeal Generator® (CSL-200-90) (K253634) | Hologic, Inc. | 2026-06-17 |
| Panther Fusion GI Expanded Bacterial Assay (K251993) | Hologic, Inc. | 2025-09-25 |
| Genius AI Detection 2.0 (K243341) | Hologic, Inc. | 2025-07-31 |
| Aptima SARS-CoV-2 Assay (K243396) | Hologic, Inc. | 2025-02-13 |
| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
| Aptima BV Assay; Aptima CV/TV Assay (K243345) | Hologic, Inc. | 2024-11-25 |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (K242465) | Hologic, Inc. | 2024-11-15 |
| Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205) (K240886) | Hologic, Inc. | 2024-07-25 |