PMA P110001S017
- Device
- RX Herculink Elite Renal Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S017
- Product code
- NIN
- Decision date
- 2021-12-08
- Generic name
- STENT, RENAL
- Approval order statement
- Update to the on-line sampling plan and the implementation of process monitoring alerts.
Current openFDA PMA Record#
- Device
- RX Herculink Elite Renal Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S017
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2021-12-08
- Decision code
- OK30
- Date received
- 2021-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the on-line sampling plan and the implementation of process monitoring alerts.