PMA P810046S199
- Device
- ACS OTW PHOTON CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S199
- Product code
- LOX
- Decision date
- 1999-10-29
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- The 30-Day Notice requested: 1) modification of the manufacturing process by which the proximal adapter is bonded to the proximal portion of the ACS OTW PHOTON(TM) Coronary Dilatation Catheter; and 2) modification of the adaptation tensile test at the finished device audit process.
Current openFDA PMA Record#
- Device
- ACS OTW PHOTON CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S199
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1999-10-29
- Decision code
- OK30
- Date received
- 1999-10-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The 30-Day Notice requested: 1) modification of the manufacturing process by which the proximal adapter is bonded to the proximal portion of the ACS OTW PHOTON(TM) Coronary Dilatation Catheter; and 2) modification of the adaptation tensile test at the finished device audit process.