PMA P810046S168
- Device
- ELIPSE 14,000.014 CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S168
- Product code
- LOX
- Decision date
- 1997-04-21
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR THE USE OF A NEW ADHESIVE IN THE MANUFACTURING OF THE ACS RX ELIPSE(TM) .014 CORONARY DILATATION CATHETER
Current openFDA PMA Record#
- Device
- ELIPSE 14,000.014 CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S168
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-04-21
- Decision code
- APPR
- Date received
- 1996-08-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE USE OF A NEW ADHESIVE IN THE MANUFACTURING OF THE ACS RX ELIPSE(TM) .014 CORONARY DILATATION CATHETER