PMA P110001S018
- Device
- RX Herculink Elite Renal Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S018
- Product code
- NIN
- Decision date
- 2022-03-24
- Generic name
- STENT, RENAL
- Approval order statement
- Updated sampling plan for an in-process device testing.
Current openFDA PMA Record#
- Device
- RX Herculink Elite Renal Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S018
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2022-03-24
- Decision code
- OK30
- Date received
- 2022-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updated sampling plan for an in-process device testing.