ENDOTAK RELIANCE 4-SITE Leads
FDA premarket approval P910073/S151 · decided 2018-11-13
Approval details
- PMA number
- P910073
- Supplement
- S151
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTAK RELIANCE 4-SITE Leads
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-10-26
- Decision date
- 2018-11-13
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.