LAMICEL(R) OSSMOTIC CERVICAL DILATOR
FDA premarket approval P820075/S005 · decided 1991-10-09
Approval details
- PMA number
- P820075
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Trade name
- LAMICEL(R) OSSMOTIC CERVICAL DILATOR
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Applicant
- Medtronic Xomed, Inc.
- Date received
- 1991-07-05
- Decision date
- 1991-10-09
- Days to decision
- 96 days
- Decision code
- APPR
- Product code
- LOB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
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510(k) clearances by this applicant
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