PON
2021-10-15
Catheter, Balloon, Dilation Of Cervical Canal
FDA product code PON · 4 cleared devices
Class 2
Obstetrics/Gynecology
- Regulation
- 21 CFR 884.4260
- Review panel
- OB
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 2016-08-01 – 2021-10-15
Mechanical dilation and softening of the cervix.
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2019-08-23
CrossBay Cervical Dilator Catheter System
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PON
2016-08-01
Aqueduct 100 Cervical Dilator
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