PMA P910073S151
- Device
- ENDOTAK RELIANCE 4-SITE Leads
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S151
- Product code
- LWS
- Decision date
- 2018-11-13
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Implementation of the following two previously accepted changes for additional models: 1) change in a reactant used for preparation of the key intermediate in the synthesis of dexamethasone acetate; and 2) addition of a pull test process monitoring step.
Current openFDA PMA Record#
- Device
- ENDOTAK RELIANCE 4-SITE Leads
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S151
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-11-13
- Decision code
- OK30
- Date received
- 2018-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of the following two previously accepted changes for additional models: 1) change in a reactant used for preparation of the key intermediate in the synthesis of dexamethasone acetate; and 2) addition of a pull test process monitoring step.