PMA P040012S049
- Device
- RX ACCULINK CARTOID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S049
- Product code
- NIM
- Decision date
- 2012-09-21
- Generic name
- Stent, carotid
- Approval order statement
- CHANGE TO THE DISPENSING SYSTEM FOR APPLYING CONTROLLED AMOUNTS OF ASSEMBLY FLUIDS DURING THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- RX ACCULINK CARTOID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S049
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2012-09-21
- Decision code
- OK30
- Date received
- 2012-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE DISPENSING SYSTEM FOR APPLYING CONTROLLED AMOUNTS OF ASSEMBLY FLUIDS DURING THE MANUFACTURING PROCESS.