PMA P160049S005
- Device
- Stellarex 0.035 OTW Drug-coated Angioplasty Ballon
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S005
- Product code
- ONU
- Decision date
- 2019-05-03
- Classification
- Drug-eluting Peripheral Transluminal Angioplasty Catheter
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Approval order statement
- Extension of the drug substance retest period and modification of heavy metals testing requirements.
Current openFDA PMA Record#
- Device
- Stellarex 0.035 OTW Drug-coated Angioplasty Ballon
- Applicant
- The Spectranetics Corp.
- PMA number
- P160049
- Supplement
- S005
- Product code
- ONU
- Generic name
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Decision date
- 2019-05-03
- Decision code
- OK30
- Date received
- 2019-04-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Extension of the drug substance retest period and modification of heavy metals testing requirements.