FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Cap, Cervical, Contraceptive
PMA: P010043
·
Decision Mar 14, 2002
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- Cap, Cervical, Contraceptive
- Trade Name
- LEA'S SHIELD BARRIER CONTRACEPTIVE
- PMA Number
- P010043
- Device Class
- FDA Class 3
- Product Code
- LLQ
- Generic Name
- Cap, cervical, contraceptive
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 14, 2002
- Date Received
- August 13, 2001
- Expedited Review
- N
- Docket Number
- 02M-0471
Advisory Committee Statement
APPROVAL FOR THE LEA'S SHIELD BARRIER CONTRACEPTIVE. THE DEVICE IS INDICATED FOR USE BY WOMEN OF CHILDBEARING AGE WHO DESIRE TO PREVENT OR POSTPONE PREGNANCY.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLQ | Cap, Cervical, Contraceptive | FDA class 3 | Unknown |