PMA P140018S012
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S012
- Product code
- PJQ
- Decision date
- 2018-09-06
- Classification
- Agent, Occluding, Vascular, Permanent
- Generic name
- Agent, occluding, vascular, permanent
- Approval order statement
- Single sample quantification of adhesive stabilizer concentration at incoming inspection and final VenaSeal adhesive formulation.
Current openFDA PMA Record#
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S012
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2018-09-06
- Decision code
- OK30
- Date received
- 2018-08-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Single sample quantification of adhesive stabilizer concentration at incoming inspection and final VenaSeal adhesive formulation.