LAMICEL(TM)
FDA premarket approval P820075/S004 · decided 1988-05-24
Approval details
- PMA number
- P820075
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LAMICEL(TM)
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Applicant
- Medtronic Xomed, Inc.
- Date received
- 1988-01-11
- Decision date
- 1988-05-24
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- LOB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
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