PMA P110001S012
- Device
- RX HERCULINK ELITE RENAL STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S012
- Product code
- NIN
- Decision date
- 2015-03-27
- Generic name
- STENT, RENAL
- Approval order statement
- ADDITION OF RECEIVING INSPECTION CAPABILITIES AT THE CLONMEL, IRELAND MANUFACTURING SITE AND CONTRACT LABORATORIES.
Current openFDA PMA Record#
- Device
- RX HERCULINK ELITE RENAL STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S012
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2015-03-27
- Decision code
- OK30
- Date received
- 2015-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF RECEIVING INSPECTION CAPABILITIES AT THE CLONMEL, IRELAND MANUFACTURING SITE AND CONTRACT LABORATORIES.