LEA'S SHIELD BARRIER CONTRACEPTIVE
FDA premarket approval P010043/S001 · decided 2004-05-26
Approval details
- PMA number
- P010043
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LEA'S SHIELD BARRIER CONTRACEPTIVE
- Generic name
- Cap, cervical, contraceptive
- Applicant
- Yama, Inc.
- Date received
- 2003-03-21
- Decision date
- 2004-05-26
- Days to decision
- 432 days
- Decision code
- APPR
- Product code
- LLQ
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Millburn, NJ
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT YAMA, INC., UNION, NEW JERSEY.
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