PMA P040012S047
- Device
- ACCULINK, RX SELF-EXPANDING CARTOID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S047
- Product code
- NIM
- Decision date
- 2012-07-11
- Generic name
- Stent, carotid
- Approval order statement
- ALIGN CLEAN ROOM ALERT LIMITS WITH A NEW STANDARD.
Current openFDA PMA Record#
- Device
- ACCULINK, RX SELF-EXPANDING CARTOID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S047
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2012-07-11
- Decision code
- OK30
- Date received
- 2012-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALIGN CLEAN ROOM ALERT LIMITS WITH A NEW STANDARD.