PMA P820075
- Device
- LAMICEL OSMOTIC CERVICAL DILATOR
- Applicant
- Medtronic Xomed, Inc.
- PMA number
- P820075
- Supplement
- S009
- Product code
- LOB
- Decision date
- 1999-07-16
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Approval order statement
- Approval for a new sterilization facility located at Sterigenics Intl., Inc., 10811 Withers Cove Park Dr., Charlotte, N.C.
Current openFDA PMA Record#
- Device
- LAMICEL OSMOTIC CERVICAL DILATOR
- Applicant
- Medtronic Xomed, Inc.
- PMA number
- P820075
- Supplement
- S009
- Product code
- LOB
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Decision date
- 1999-07-16
- Decision code
- APPR
- Date received
- 1999-06-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- Approval for a new sterilization facility located at Sterigenics Intl., Inc., 10811 Withers Cove Park Dr., Charlotte, N.C.