PMA P110001S015
- Device
- RX Herculink Elite Renal and Biliary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S015
- Product code
- NIN
- Decision date
- 2021-06-22
- Generic name
- STENT, RENAL
- Approval order statement
- Change to the sub-assembly stent inspection process to increase manufacturing efficiency.
Current openFDA PMA Record#
- Device
- RX Herculink Elite Renal and Biliary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S015
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2021-06-22
- Decision code
- OK30
- Date received
- 2021-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the sub-assembly stent inspection process to increase manufacturing efficiency.