PMA P040038S035
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S035
- Product code
- NIM
- Decision date
- 2019-03-14
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- Modification to the ethylene oxide sterilization dunnage configuration layers and pallet dimensions.
Current openFDA PMA Record#
- Device
- XACT Carotid Stent System
- Applicant
- Abbott Vascular, Inc.
- PMA number
- P040038
- Supplement
- S035
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2019-03-14
- Decision code
- OK30
- Date received
- 2019-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the ethylene oxide sterilization dunnage configuration layers and pallet dimensions.