PMA P820075S008
- Device
- LAMICEL OSMOTIC CERVICAL DILATOR
- Applicant
- Medtronic Xomed, Inc.
- PMA number
- P820075
- Supplement
- S008
- Product code
- LOB
- Decision date
- 1999-07-09
- Generic name
- Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
- Approval order statement
- The 30-Day Notice Requested A Change In The Approved Sterilization Process Of E-beam To Gamma Radiation Process.
Current openFDA PMA Record
- Device
- LAMICEL OSMOTIC CERVICAL DILATOR
- Applicant
- Medtronic Xomed, Inc.
- PMA number
- P820075
- Supplement
- S008
- Product code
- LOB
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Decision date
- 1999-07-09
- Decision code
- OK30
- Date received
- 1999-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested a change in the approved sterilization process of e-beam to gamma radiation process.