PMA P820075S007
- Device
- LAMICEL(R) OSMOSTIC CERVICAL DILATOR
- Applicant
- Medtronic Xomed, Inc.
- PMA number
- P820075
- Supplement
- S007
- Product code
- LOB
- Decision date
- 1996-01-03
- Generic name
- Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination
- Approval order 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
Current openFDA PMA Record
- Device
- LAMICEL(R) OSMOSTIC CERVICAL DILATOR
- Applicant
- Medtronic Xomed, Inc.
- PMA number
- P820075
- Supplement
- S007
- Product code
- LOB
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Decision date
- 1996-01-03
- Decision code
- APPR
- Date received
- 1995-05-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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