PMA P990008
- Device
- COOK MBC PTCA BALLOON DILATATION CATHETER
- Applicant
- Cook, Inc.
- PMA number
- P990008
- Product code
- LOX
- Decision date
- 1999-09-27
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- Approval for the Cook(R) MBC PTCA Balloon Dilatation Catheter (sizes noted in the enclosure). This device is indicated for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for th epurpose of improving myocardial perfusion.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P990008B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record
- Device
- COOK MBC PTCA BALLOON DILATATION CATHETER
- Applicant
- Cook, Inc.
- PMA number
- P990008
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1999-09-27
- Decision code
- APWD
- Date received
- 1999-02-11
- Approval order statement
- Approval for the Cook(R) MBC PTCA Balloon Dilatation Catheter (sizes noted in the enclosure). This device is indicated for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for th epurpose of improving myocardial perfusion.