PMA P980023S079
- Device
- Protego TD 75/18, 65/18, 65/16; T 65; SD 75/18, 65/18, 65/16, 60/16, S75, S65, S60; Protego DF-1 TD 75/18, 65/18, 65/16;
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S079
- Product code
- LWS
- Decision date
- 2016-12-19
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Alternate supplier for the iridium coating process.
Current openFDA PMA Record#
- Device
- Protego TD 75/18, 65/18, 65/16; T 65; SD 75/18, 65/18, 65/16, 60/16, S75, S65, S60; Protego DF-1 TD 75/18, 65/18, 65/16;
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S079
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2016-12-19
- Decision code
- OK30
- Date received
- 2016-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier for the iridium coating process.