PMA P110001S001
- Device
- RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S001
- Product code
- NIN
- Decision date
- 2011-09-21
- Generic name
- STENT, RENAL
- Approval order statement
- CHANGES TO THE SOLUTION MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- RX HERCULINK ELITE RENAL AND BILIARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S001
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2011-09-21
- Decision code
- OK30
- Date received
- 2011-08-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE SOLUTION MANUFACTURING PROCESS.