PMA P050018S014
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S014
- Product code
- NWX
- Decision date
- 2011-05-12
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- MANUFACTURING CHANGE TO INCLUDE A NEW PART NUMBER FOR THE DEVICE AND THE PURCHASE OF THE OEM RAPID EXCHANGE BALLOON CATHETER MANUFACTURED BY A QUALIFIED SUPPLIER.
Current openFDA PMA Record#
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER,RAPID EXCHANGE (RX0
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S014
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2011-05-12
- Decision code
- OK30
- Date received
- 2011-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING CHANGE TO INCLUDE A NEW PART NUMBER FOR THE DEVICE AND THE PURCHASE OF THE OEM RAPID EXCHANGE BALLOON CATHETER MANUFACTURED BY A QUALIFIED SUPPLIER.