LEA'S SHIELD BARRIER CONTRACEPTIVE
FDA premarket approval P010043 · decided 2002-03-14
Approval details
- PMA number
- P010043
- Trade name
- LEA'S SHIELD BARRIER CONTRACEPTIVE
- Generic name
- Cap, cervical, contraceptive
- Applicant
- Yama, Inc.
- Date received
- 2001-08-13
- Decision date
- 2002-03-14
- Days to decision
- 213 days
- Decision code
- APPR
- Product code
- LLQ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Millburn, NJ
- 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.
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