PMA P110001S011
- Device
- RX HERCULINK ELITE RENAL STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S011
- Product code
- NIN
- Decision date
- 2014-06-06
- Generic name
- STENT, RENAL
- Approval order statement
- APPROVAL FOR A LABELING UPDATE BASED ON THE POST-APPROVAL STUDY RESULTS.
Current openFDA PMA Record#
- Device
- RX HERCULINK ELITE RENAL STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S011
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2014-06-06
- Decision code
- APPR
- Date received
- 2013-12-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A LABELING UPDATE BASED ON THE POST-APPROVAL STUDY RESULTS.