PMA P030047S055
- Device
- PRECISE PRO RX Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S055
- Product code
- NIM
- Decision date
- 2026-06-05
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- Approval for labeling updates.
Current openFDA PMA Record#
- Device
- PRECISE PRO RX Nitinol Stent System
- Applicant
- Cordis US Corporation
- PMA number
- P030047
- Supplement
- S055
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2026-06-05
- Decision code
- APPR
- Date received
- 2026-05-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates.