PMA P030047S053
- Device
- PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S053
- Product code
- NIM
- Decision date
- 2026-01-08
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- approval to change the receiving inspection level for 15 part numbers
Current openFDA PMA Record#
- Device
- PRECISE® PRO RX Nitinol Stent System; PRECISE® PRO Transcarotid Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S053
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2026-01-08
- Decision code
- OK30
- Date received
- 2025-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to change the receiving inspection level for 15 part numbers