PMA P960006S047
- Device
- Sweet Tip(R) RX Steroid Eluting Lead
- Applicant
- Boston Scientific
- PMA number
- P960006
- Supplement
- S047
- Product code
- NVN
- Decision date
- 2018-04-25
- Classification
- Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Updates to the BET test method.
Current openFDA PMA Record#
- Device
- Sweet Tip(R) RX Steroid Eluting Lead
- Applicant
- Boston Scientific
- PMA number
- P960006
- Supplement
- S047
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2018-04-25
- Decision code
- OK30
- Date received
- 2018-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the BET test method.