PMA P110001S021
- Device
- RX HERCULINK ELITE RENAL STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S021
- Product code
- NIN
- Decision date
- 2025-07-02
- Classification
- Cardiovascular
- Generic name
- STENT, RENAL
- Approval order statement
- reduced incoming inspection plan for the cobalt chromium tubing
Current openFDA PMA Record#
- Device
- RX HERCULINK ELITE RENAL STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S021
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2025-07-02
- Decision code
- OK30
- Date received
- 2025-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reduced incoming inspection plan for the cobalt chromium tubing