LAMICEL OSMOTIC CERVICAL DILATOR
FDA premarket approval P820075/S009 · decided 1999-07-16
Approval details
- PMA number
- P820075
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- LAMICEL OSMOTIC CERVICAL DILATOR
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Applicant
- Medtronic Xomed, Inc.
- Date received
- 1999-06-24
- Decision date
- 1999-07-16
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LOB
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Jacksonville, FL
- Statement
- Approval for a new sterilization facility located at Sterigenics Intl., Inc., 10811 Withers Cove Park Dr., Charlotte, N.C.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080) (K251672) | Medtronic Xomed, Inc. | 2026-02-10 |
| 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 |