FILSHIE CLIP (MARK VI) SYSTEM
FDA premarket approval P920046 · decided 1996-09-05
Approval details
- PMA number
- P920046
- Trade name
- FILSHIE CLIP (MARK VI) SYSTEM
- Generic name
- Laparoscopic contraceptive tubal occlusion device
- Applicant
- Femcare , Ltd.
- Date received
- 1992-09-10
- Decision date
- 1996-09-05
- Days to decision
- 1456 days
- Decision code
- APPR
- Product code
- KNH
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Romsey
- Statement
- APPROVAL FOR THE FILSHIE CLIP SYSTEM (MARK VI). THE DEVICE IS A CONTRACEPTIVE TUBAL OCCLUSION DEVICE (TOD)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LI VASECTOMY (K932465) | Femcare , Ltd. | 1994-03-02 |
| ADD-A-CATH (K884061) | Femcare , Ltd. | 1988-10-25 |