PMA P040012S035
- Device
- ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S035
- Product code
- NIM
- Decision date
- 2010-11-01
- Generic name
- Stent, carotid
- Approval order statement
- DISCONTINUATION OF THE QUARTERLY PYROGEN TESTING OF THE ABOVE NAMED PRE- AND POST-E-BEAM STERILIZED PRODUCTS.
Current openFDA PMA Record#
- Device
- ACCULINK CAROTID STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P040012
- Supplement
- S035
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2010-11-01
- Decision code
- OK30
- Date received
- 2010-10-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- DISCONTINUATION OF THE QUARTERLY PYROGEN TESTING OF THE ABOVE NAMED PRE- AND POST-E-BEAM STERILIZED PRODUCTS.