LAMICEL(R) OSMOSTIC CERVICAL DILATOR
FDA premarket approval P820075/S007 · decided 1996-01-03
Approval details
- PMA number
- P820075
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LAMICEL(R) OSMOSTIC CERVICAL DILATOR
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Applicant
- Medtronic Xomed, Inc.
- Date received
- 1995-05-22
- Decision date
- 1996-01-03
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- LOB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- APPROVAL FOR RELOCATING CABOT'S LAMICEL PROCESSING EQUIPMENT AND THE ASSOCIATED METHODS OR PROCEDURESTO THE MEROCEL FACILITY AT 950 FLANDERS ROAD, MYSTIC, CONNECTICUT, 06355
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510(k) clearances by this applicant
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|---|---|---|
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| NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube (K230320) | Medtronic Xomed, Inc. | 2023-10-26 |
| NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (K231580) | Medtronic Xomed, Inc. | 2023-08-30 |
| NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (K213246) | Medtronic Xomed, Inc. | 2022-03-21 |
| NuVent Eustachian Tube Dilation Balloon (K210841) | Medtronic Xomed, Inc. | 2021-08-16 |
| NIM Vital, Nerve Integrity Monitor (K200759) | Medtronic Xomed, Inc. | 2020-10-28 |
| Sharpsite AC Rigid Endsocope (K173855) | Medtronic Xomed, Inc. | 2018-04-20 |
| NuVent EM Sinus Dilation System (K152121) | Medtronic Xomed, Inc. | 2015-12-01 |