PMA P820075S006
- Device
- LAMICEL(R) OSSMOTIC CERVICAL DILATOR
- Applicant
- Medtronic Xomed, Inc.
- PMA number
- P820075
- Supplement
- S006
- Product code
- LOB
- Decision date
- 1995-10-10
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Approval order statement
- APPROVAL FOR NEW ACCELERATED TESTING PROTOCOL TO ESTABLISH THE SHELF-LIFE OF YOUR PRODUCT TO 24 MONTHS
Current openFDA PMA Record#
- Device
- LAMICEL(R) OSSMOTIC CERVICAL DILATOR
- Applicant
- Medtronic Xomed, Inc.
- PMA number
- P820075
- Supplement
- S006
- Product code
- LOB
- Generic name
- dilator, cervical, synthetic, osmotic, pregnancy termination
- Decision date
- 1995-10-10
- Decision code
- APPR
- Date received
- 1995-05-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR NEW ACCELERATED TESTING PROTOCOL TO ESTABLISH THE SHELF-LIFE OF YOUR PRODUCT TO 24 MONTHS