PMA P810046S209
- Device
- PERCUTANEOUS CORONARY DILATATION CATHETERS
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S209
- Product code
- LOX
- Decision date
- 2001-08-22
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR MODIFICATIONS IN THE INSTRUCTIONS FOR USE BOOKLETS OF THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), ACS OTW PHOTON(TM), ACS RX GEMINI(TM), AND ACS RX ESPRIT PTCA CATHETERS.
Current openFDA PMA Record#
- Device
- PERCUTANEOUS CORONARY DILATATION CATHETERS
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S209
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2001-08-22
- Decision code
- APPR
- Date received
- 2001-05-17
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS IN THE INSTRUCTIONS FOR USE BOOKLETS OF THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), ACS OTW PHOTON(TM), ACS RX GEMINI(TM), AND ACS RX ESPRIT PTCA CATHETERS.