PMA P110001S006
- Device
- HERCULINK ELITE PERIPHERAL STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S006
- Product code
- NIN
- Decision date
- 2012-07-11
- Generic name
- STENT, RENAL
- Approval order statement
- ALIGN CLEAN ROOM ALERT LIMITS WITH A NEW STANDARD.
Current openFDA PMA Record#
- Device
- HERCULINK ELITE PERIPHERAL STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P110001
- Supplement
- S006
- Product code
- NIN
- Generic name
- STENT, RENAL
- Decision date
- 2012-07-11
- Decision code
- OK30
- Date received
- 2012-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALIGN CLEAN ROOM ALERT LIMITS WITH A NEW STANDARD.